cyanocobalamin

Generic: cyanocobalamin

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyanocobalamin
Generic Name cyanocobalamin
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR SUBCUTANEOUS
Active Ingredients

cyanocobalamin 1000 ug/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-301
Product ID 71288-301_b2ee60e7-c10a-45e1-81e8-28d6838161eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214316
Listing Expiration 2026-12-31
Marketing Start 2024-11-15

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 71288301
Hyphenated Format 71288-301

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 ANDA214316 (source: ndc)
Routes
INTRAMUSCULAR SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1000 ug/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (71288-301-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-301-10)
source: ndc

Packages (1)

71288-301-11 10 VIAL, MULTI-DOSE in 1 CARTON (71288-301-11) / 10 mL in 1 VIAL, MULTI-DOSE (71288-301-10)

Ingredients (1)

cyanocobalamin (1000 ug/mL)

Linked Drug Pages (1)

Cyanocobalamin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "SUBCUTANEOUS"], "spl_id": "b2ee60e7-c10a-45e1-81e8-28d6838161eb", "openfda": {"nui": ["M0022794", "N0000175951"], "unii": ["P6YC3EG204"], "rxcui": ["309594"], "spl_set_id": ["9c37fd25-2143-410c-8d89-d39aa5c7b453"], "pharm_class_cs": ["Vitamin B 12 [CS]"], "pharm_class_epc": ["Vitamin B12 [EPC]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (71288-301-11)  / 10 mL in 1 VIAL, MULTI-DOSE (71288-301-10)", "package_ndc": "71288-301-11", "marketing_start_date": "20241115"}], "brand_name": "Cyanocobalamin", "product_id": "71288-301_b2ee60e7-c10a-45e1-81e8-28d6838161eb", "dosage_form": "INJECTION", "pharm_class": ["Vitamin B 12 [CS]", "Vitamin B12 [EPC]"], "product_ndc": "71288-301", "generic_name": "Cyanocobalamin", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyanocobalamin", "active_ingredients": [{"name": "CYANOCOBALAMIN", "strength": "1000 ug/mL"}], "application_number": "ANDA214316", "marketing_category": "ANDA", "marketing_start_date": "20241115", "listing_expiration_date": "20261231"}