cyanocobalamin

Generic: cyanocobalamin

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyanocobalamin
Generic Name cyanocobalamin
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR SUBCUTANEOUS
Active Ingredients

cyanocobalamin 1000 ug/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-044
Product ID 63323-044_634b55ef-9667-46f7-9b3e-d41f4b7b819b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080557
Listing Expiration 2026-12-31
Marketing Start 2000-10-18

Pharmacologic Class

Established (EPC)
vitamin b12 [epc]
Chemical Structure
vitamin b 12 [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323044
Hyphenated Format 63323-044

Supplemental Identifiers

RxCUI
309594
UNII
P6YC3EG204
NUI
M0022794 N0000175951

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 cyanocobalamin (source: ndc)
Generic Name cyanocobalamin (source: ndc)
Application Number ANDA080557 (source: ndc)
Routes
INTRAMUSCULAR SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1000 ug/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-01) / 1 mL in 1 VIAL, MULTI-DOSE (63323-044-00)
source: ndc

Packages (1)

63323-044-01 25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-01) / 1 mL in 1 VIAL, MULTI-DOSE (63323-044-00)

Ingredients (1)

cyanocobalamin (1000 ug/mL)

Linked Drug Pages (2)

Cyanocobalamin ndc-match (0.9) Cyanocobalamin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "SUBCUTANEOUS"], "spl_id": "634b55ef-9667-46f7-9b3e-d41f4b7b819b", "openfda": {"nui": ["M0022794", "N0000175951"], "unii": ["P6YC3EG204"], "rxcui": ["309594"], "spl_set_id": ["acff4ff3-4435-4995-a117-dbfcdf72334a"], "pharm_class_cs": ["Vitamin B 12 [CS]"], "pharm_class_epc": ["Vitamin B12 [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-044-01)  / 1 mL in 1 VIAL, MULTI-DOSE (63323-044-00)", "package_ndc": "63323-044-01", "marketing_start_date": "20001018"}], "brand_name": "Cyanocobalamin", "product_id": "63323-044_634b55ef-9667-46f7-9b3e-d41f4b7b819b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Vitamin B 12 [CS]", "Vitamin B12 [EPC]"], "product_ndc": "63323-044", "generic_name": "CYANOCOBALAMIN", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyanocobalamin", "active_ingredients": [{"name": "CYANOCOBALAMIN", "strength": "1000 ug/mL"}], "application_number": "ANDA080557", "marketing_category": "ANDA", "marketing_start_date": "20001018", "listing_expiration_date": "20261231"}