NDC 0591-2888

Hydroxocobalamin

Hydroxocobalamin

Hydroxocobalamin is a Intramuscular Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Hydroxocobalamin Acetate.

• Product ID: 0591-2888_8aba3d27-2891-4595-85be-87a2cf1c5dd9
• NDC: 0591-2888
• Product Type: Human Prescription Drug
• Proprietary Name: Hydroxocobalamin
• Generic Name: Hydroxocobalamin
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2010-11-12
• Marketing Category: ANDA / ANDA
• Application Number: ANDA085998
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: HYDROXOCOBALAMIN ACETATE
• Active Ingredient Strength: 1000 ug/mL
• Pharm Classes: Antidote [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0591-2888-30

1 VIAL, MULTI-DOSE in 1 CARTON (0591-2888-30) > 30 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2010-11-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-2888-30 [00591288830]

Hydroxocobalamin INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA085998
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-11-12

Drug Details

Active Ingredients

Ingredient	Strength
HYDROXOCOBALAMIN ACETATE	1000 ug/mL

OpenFDA Data

• SPL SET ID: a3087a39-f218-4f16-a1e7-17c39bb2eb69
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • S535M27N3Q
• RxNorm Concept Unique ID - RxCUI:
  • 317106

Pharmacological Class

• Antidote [EPC]
• Antidote [EPC]

NDC Crossover Matching brand name "Hydroxocobalamin" or generic name "Hydroxocobalamin"

NDC	Brand Name	Generic Name
0591-2888	Hydroxocobalamin	Hydroxocobalamin
50090-3548	Hydroxocobalamin	Hydroxocobalamin
11704-370	Cyanokit	Hydroxocobalamin
50633-310	Cyanokit	Hydroxocobalamin