NDC 65293-426

Rocuronium

Rocuronium Bromide

Rocuronium is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by The Medicines Company. The primary component is Rocuronium Bromide.

• Product ID: 65293-426_515789db-9048-40fe-ba91-ce61ddcd6f4e
• NDC: 65293-426
• Product Type: Human Prescription Drug
• Proprietary Name: Rocuronium
• Generic Name: Rocuronium Bromide
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2009-12-13
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078651
• Labeler Name: The Medicines Company
• Substance Name: ROCURONIUM BROMIDE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Neuromuscular Nondepolarizing Blockade [PE],Nondepolarizing Neuromuscular Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 65293-426-10

10 VIAL in 1 TRAY (65293-426-10) > 5 mL in 1 VIAL (65293-426-05)

• Marketing Start Date: 2009-12-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65293-426-05 [65293042605]

Rocuronium INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078651
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-12-13
• Marketing End Date: 2015-03-31

NDC 65293-426-10 [65293042610]

Rocuronium INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078651
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-01-17
• Marketing End Date: 2015-03-31

Drug Details

Active Ingredients

Ingredient	Strength
ROCURONIUM BROMIDE	10 mg/mL

OpenFDA Data

• SPL SET ID: 6ec8c417-6613-45e0-bc86-293a8b1ee83f
• Manufacturer:
  • The Medicines Company
• UNII:
  • I65MW4OFHZ
• RxNorm Concept Unique ID - RxCUI:
  • 1234995

Pharmacological Class

• Neuromuscular Nondepolarizing Blockade [PE]
• Nondepolarizing Neuromuscular Blocker [EPC]

NDC Crossover Matching brand name "Rocuronium" or generic name "Rocuronium Bromide"

NDC	Brand Name	Generic Name
63323-426	Rocuronium	Rocuronium
65293-427	Rocuronium	Rocuronium
65293-426	Rocuronium	Rocuronium
66794-228	Rocuronium	Rocuronium
66794-229	Rocuronium	Rocuronium
0143-9250	Rocuronium Bromide	Rocuronium Bromide
0143-9251	Rocuronium Bromide	Rocuronium Bromide
0409-9558	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE
0703-2394	Rocuronium Bromide	Rocuronium Bromide
0703-2395	Rocuronium Bromide	Rocuronium Bromide
0781-3220	Rocuronium Bromide	Rocuronium Bromide
25021-662	rocuronium bromide	rocuronium bromide
39822-4200	rocuronium bromide	rocuronium bromide
43066-007	Rocuronium Bromide	Rocuronium Bromide
43066-013	Rocuronium Bromide	Rocuronium Bromide
43547-530	ROCURONIUM BROMIDE	rocuronium bromide
43547-531	ROCURONIUM BROMIDE	rocuronium bromide
47781-616	Rocuronium Bromide	rocuronium bromide
47781-617	Rocuronium Bromide	rocuronium bromide
51662-1354	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE
51662-1355	ROCURONIUM BROMIDE	ROCURONIUM BROMIDE