Post on 04-Apr-2022
transcript
THE DISTINCTION INCOMPOUNDING IS AUTOMATION
THE DISTINCTION IN
COMPOUNDING IS AUTOMATION
Product CatalogAPRIL 2022
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
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.
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.
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
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.
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: customerservice@SterRx.com
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