hydroxocobalamin

Generic: hydroxocobalamin

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxocobalamin
Generic Name hydroxocobalamin
Labeler actavis pharma, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

hydroxocobalamin acetate 1000 ug/mL

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2888
Product ID 0591-2888_c47477bf-6413-4699-ab77-c5441a9d1557
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA085998
Listing Expiration 2026-12-31
Marketing Start 2010-11-12

Pharmacologic Class

Classes
antidote [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05912888
Hyphenated Format 0591-2888

Supplemental Identifiers

RxCUI
317106
UNII
S535M27N3Q

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydroxocobalamin (source: ndc)
Generic Name hydroxocobalamin (source: ndc)
Application Number ANDA085998 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 1000 ug/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (0591-2888-30) / 30 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

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

Ingredients (1)

hydroxocobalamin acetate (1000 ug/mL)

Linked Drug Pages (1)

Hydroxocobalamin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "c47477bf-6413-4699-ab77-c5441a9d1557", "openfda": {"unii": ["S535M27N3Q"], "rxcui": ["317106"], "spl_set_id": ["a3087a39-f218-4f16-a1e7-17c39bb2eb69"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (0591-2888-30)  / 30 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0591-2888-30", "marketing_start_date": "20101112"}], "brand_name": "Hydroxocobalamin", "product_id": "0591-2888_c47477bf-6413-4699-ab77-c5441a9d1557", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antidote [EPC]"], "product_ndc": "0591-2888", "generic_name": "Hydroxocobalamin", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxocobalamin", "active_ingredients": [{"name": "HYDROXOCOBALAMIN ACETATE", "strength": "1000 ug/mL"}], "application_number": "ANDA085998", "marketing_category": "ANDA", "marketing_start_date": "20101112", "listing_expiration_date": "20261231"}