NDC 68083-365

Rocuronium Bromide

Rocuronium Bromide

Rocuronium Bromide is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Rocuronium Bromide.

• Product ID: 68083-365_0335fa9d-ed70-428c-b6a6-df44f8ba15e8
• NDC: 68083-365
• Product Type: Human Prescription Drug
• Proprietary Name: Rocuronium Bromide
• Generic Name: Rocuronium Bromide
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-05-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205656
• Labeler Name: Gland Pharma Limited
• 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 68083-365-10

10 VIAL, MULTI-DOSE in 1 CARTON (68083-365-10) > 10 mL in 1 VIAL, MULTI-DOSE (68083-365-01)

• Marketing Start Date: 2018-05-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68083-365-01 [68083036501]

Rocuronium Bromide INJECTION

• Marketing Category: ANDA
• Application Number: ANDA205656
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-05-18

NDC 68083-365-10 [68083036510]

Rocuronium Bromide INJECTION

• Marketing Category: ANDA
• Application Number: ANDA205656
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-05-18

Drug Details

Active Ingredients

Ingredient	Strength
ROCURONIUM BROMIDE	10 mg/mL

OpenFDA Data

• SPL SET ID: a223a740-dbe8-4d06-8b8b-d9104b694e62
• Manufacturer:
  • Gland Pharma Limited
• UNII:
  • I65MW4OFHZ
• RxNorm Concept Unique ID - RxCUI:
  • 1234995

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
68083-364	Rocuronium Bromide	Rocuronium Bromide
68083-365	Rocuronium Bromide	Rocuronium Bromide
70860-651	Rocuronium Bromide	Rocuronium Bromide
71872-7036	rocuronium bromide	rocuronium bromide
55150-225	Rocuronium Bromide	Rocuronium Bromide
55150-226	Rocuronium Bromide	Rocuronium Bromide
59651-115	Rocuronium Bromide	Rocuronium Bromide
59651-116	Rocuronium Bromide	Rocuronium Bromide
67457-228	Rocuronium Bromide	Rocuronium Bromide
67457-573	Rocuronium Bromide	Rocuronium Bromide
67457-574	Rocuronium Bromide	Rocuronium Bromide
55579-400	Rocuronium Bromide	Rocuronium Bromide
71479-004	Rocuronium bromide	Rocuronium bromide