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THE DISTINCTION IN COMPOUNDING IS AUTOMATION THE DISTINCTION IN COMPOUNDING IS AUTOMATION Product Catalog APRIL 2022
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Page 1: THE DISTINCTION IN COMPOUNDING THE DISTINCTION IN ...

THE DISTINCTION INCOMPOUNDING IS AUTOMATION

THE DISTINCTION IN

COMPOUNDING IS AUTOMATION

Product CatalogAPRIL 2022

Page 2: THE DISTINCTION IN COMPOUNDING THE DISTINCTION IN ...

Products compounded by SterRx in accordance with Section 503B are statutorily exempt from FDA’s drug approval and adequate directions for use requirements in FDCASections 505 and 502(f)(1). SterRx® compounded formulations are not FDA-approved or reviewed by FDA for safety or efficacy.

Automation is used in compounding, sterilizing, filling and sealing of the finished product. Post-production processes such as labeling and packing are performedmanually.

SterRx.com | 1.844.319.7799 1

SterRx® is an FDA-registered 503B outsourcing facility that manufactures high-qualitycGMP-compliant products with minimal human intervention. Our asepticmanufacturing process uses automation in the compounding, sterilizing, filling andsealing of finished product — no hoods. When you outsource your compounding toSterRx, you can be confident in the quality of the product and the efficiency of youroperation.

THERAPEUTIC CLASSESALKALINIZING AGENT

· Sodium Bicarbonate

CALCIUM-CHANNEL BLOCKING AGENTS

· Diltiazem

NEUROMUSCULAR BLOCKING AGENT

· Succinylcholine

OPIATE AGONISTS

· Fentanyl Citrate· Morphine Sulfate

SEDATIVES

· Midazolam

VASOPRESSORS

· Epinephrine· Norepinephrine· Phenylephrine

Page 3: THE DISTINCTION IN COMPOUNDING THE DISTINCTION IN ...

Products compounded by SterRx in accordance with Section 503B are statutorily exempt from FDA’s drug approval and adequate directions for use requirements in FDCASections 505 and 502(f)(1). SterRx® compounded formulations are not FDA-approved or reviewed by FDA for safety or efficacy.

Automation is used in compounding, sterilizing, filling and sealing of the finished product. Post-production processes such as labeling and packing are performedmanually.

SterRx.com | 1.844.319.7799 2

Product ListNDC# CONFIGURATION DESCRIPTION* STRENGTH CONTAINER

TYPEUNITS/CASE

EXPIRYDATING

DILTIAZEM

70324-976-01 125 mg Diltiazem HClin 0.7% Sodium Chloride Injection 125 mL (1 mg/mL)

125 mg per 125 mL IV bag 20 240-day RT

70324-951-01 125 mg Diltiazem HClin 5% Dextrose Injection 125 mL (1 mg/mL)

125 mg per 125 mL IV bag 20 180-day RT

EPINEPHRINE

70324-027-01 2 mg Epinephrinein 0.9% Sodium Chloride Injection 250 mL (8 mcg/mL)

2 mg per 250 mL Blow-fill-seal (BFS)IV bag

12 360-day RT

70324-227-01 4 mg Epinephrinein 0.9% Sodium Chloride Injection 250 mL (16 mcg/mL)

4 mg per 250 mL BFS IV bag 12 360-day RT

70324-052-01 5 mg Epinephrinein 0.9% Sodium Chloride Injection 250 mL (20 mcg/mL)

5 mg per 250 mL BFS IV bag 12 240-day RT

70324-077-01 8 mg Epinephrinein 0.9% Sodium Chloride Injection 250 mL (32 mcg/mL)

8 mg per 250 mL BFS IV bag 12 360-day RT

70324-627-01 16 mg Epinephrinein 0.9% Sodium Chloride Injection 250 mL (64 mcg/mL)

16 mg per 250 mL BFS IV bag 12 180-day RT

FENTANYL CITRATE

70324-327-01 1 mg Fentanyl Citratein 0.9% Sodium Chloride Injection 100 mL (10 mcg/mL)

1 mg per 100 mL IV bag 20 240-day RT

70324-327-02 2.5 mg Fentanyl Citratein 0.9% Sodium Chloride Injection 250 mL (10 mcg/mL)

2.5 mg per 250 mL IV bag 20 240-day RT

*Products are preservative-free, PVC-free, DEHP-free and latex-free.

Page 4: THE DISTINCTION IN COMPOUNDING THE DISTINCTION IN ...

Products compounded by SterRx in accordance with Section 503B are statutorily exempt from FDA’s drug approval and adequate directions for use requirements in FDCASections 505 and 502(f)(1). SterRx® compounded formulations are not FDA-approved or reviewed by FDA for safety or efficacy.

Automation is used in compounding, sterilizing, filling and sealing of the finished product. Post-production processes such as labeling and packing are performedmanually.

SterRx.com | 1.844.319.7799 3

Product ListNDC# CONFIGURATION DESCRIPTION* STRENGTH CONTAINER

TYPEUNITS/CASE

EXPIRYDATING

MIDAZOLAM

70324-102-02 100 mg Midazolamin 0.9% Sodium Chloride Injection 100 mL (1 mg/mL)

100 mg per 100 mL IV bag 20 360-day RT

MORPHINE SULFATE

70324-402-01 2 mg Morphine Sulfatein 0.9% Sodium Chloride Injection 1 mL (2 mg/mL)

2 mg per mL Syringe 20 180-day RT

70324-402-02 4 mg Morphine Sulfatein 0.9% Sodium Chloride Injection 2 mL (2 mg/mL)

4 mg per 2 mL Syringe 20 180-day RT

70324-427-01 50 mg Morphine Sulfatein 0.9% Sodium Chloride Injection 50 mL (1 mg per mL)

50 mg per 50 mL IV bag 20 180-day RT

70324-427-02 100 mg Morphine Sulfatein 0.9% Sodium Chloride Injection 100 mL (1 mg permL)

100 mg per 100 mL IV bag 20 180-day RT

70324-452-01 100 mg Morphine Sulfatein 5% Dextrose Injection 100 mL (1 mg per mL)

100 mg per 100 mL IV bag 20 180-day RT

*Products are preservative-free, PVC-free, DEHP-free and latex-free.

Page 5: THE DISTINCTION IN COMPOUNDING THE DISTINCTION IN ...

Products compounded by SterRx in accordance with Section 503B are statutorily exempt from FDA’s drug approval and adequate directions for use requirements in FDCASections 505 and 502(f)(1). SterRx® compounded formulations are not FDA-approved or reviewed by FDA for safety or efficacy.

Automation is used in compounding, sterilizing, filling and sealing of the finished product. Post-production processes such as labeling and packing are performedmanually.

SterRx.com | 1.844.319.7799 4

Product ListNDC# CONFIGURATION DESCRIPTION* STRENGTH CONTAINER

TYPEUNITS/CASE

EXPIRYDATING

NOREPINEPHRINE

70324-552-01 4 mg Norepinephrinein 0.9% Sodium Chloride Injection 250 mL (16 mcg/mL)(sulfite-free)

4 mg per 250 mL Blow-Fill-Seal (BFS)IV bag

12 360-day RT

70324-577-01 8 mg Norepinephrinein 0.9% Sodium Chloride Injection 250 mL (32 mcg/mL)(sulfite-free)

8 mg per 250 mL BFS IV bag 12 360-day RT

70324-602-01 16 mg Norepinephrinein 0.9% Sodium Chloride Injection 250 mL (64 mcg/mL)(sulfite-free)

16 mg per 250 mL BFS IV bag 12 360-day RT

70324-702-01 32 mg Norepinephrinein 0.9% Sodium Chloride Injection 250 mL (128mcg/mL)(sulfite-free)

32 mg per 250 mL BFS IV bag 12 180-day RT

PHENYLEPHRINE

70324-701-01 20 mg Phenylephrine HClin 0.9% Sodium Chloride Injection 250 mL (80 mcg/mL)

20 mg per 250 mL Blow-Fill-Seal (BFS)IV bag

12 300-day RT

70324-252-01 40 mg Phenylephrine HClin 0.9% Sodium Chloride Injection 250 mL (160mcg/mL)

40 mg per 250 mL BFS IV bag 12 300-day RT

70324-901-01 50 mg Phenylephrine HClin 0.9% Sodium Chloride Injection 250 mL (200mcg/mL)

50 mg per 250 mL BFS IV bag 12 300-day RT

SODIUM BICARBONATE

70324-326-01 150 mEq Sodium Bicarbonatein 5% Dextrose Injection 1,000 mL (12.6 mg/mL)

150 mEq per 1,000mL

BFS IV bag 6 330-day RT

SUCCINYLCHOLINE

Page 6: THE DISTINCTION IN COMPOUNDING THE DISTINCTION IN ...

Products compounded by SterRx in accordance with Section 503B are statutorily exempt from FDA’s drug approval and adequate directions for use requirements in FDCASections 505 and 502(f)(1). SterRx® compounded formulations are not FDA-approved or reviewed by FDA for safety or efficacy.

Automation is used in compounding, sterilizing, filling and sealing of the finished product. Post-production processes such as labeling and packing are performedmanually.

SterRx.com | 1.844.319.7799 5

70324-826-01 200 mg SuccinylcholineChloride Injection 10 mL (20 mg/mL)

200 mg per 10 mL Syringe 12 105-day RT

*Products are preservative-free, PVC-free, DEHP-free and latex-free.

Page 7: THE DISTINCTION IN COMPOUNDING THE DISTINCTION IN ...

Contact your local SAGENT®representative to learn

how SterRx ready-to-use compounded products can

benefit your facility.

REQUEST PORTAL ACCESS: order.sterrx.com

EMAIL: [email protected]

CALL TOLL FREE: 1-844-319-7799

SterRx is a registered trademark of SterRx, LLC.

SAGENT is a registered trademark of Sagent Pharmaceuticals, Inc.

©2022 SterRx, LLC. SPM20-0112


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