cyanocobalamin

Generic: cyanocobalamin

Labeler: auromedics pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyanocobalamin
Generic Name cyanocobalamin
Labeler auromedics pharma llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

cyanocobalamin 1000 ug/mL

Manufacturer
AuroMedics Pharma LLC

Identifiers & Regulatory

Product NDC 55150-364
Product ID 55150-364_a0566c8d-7cb0-4ee7-8599-f2e8dc8992c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213874
Listing Expiration 2026-12-31
Marketing Start 2020-12-08

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 55150364
Hyphenated Format 55150-364

Supplemental Identifiers

RxCUI
309594
UPC
0355150364015 0355150364107
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 ANDA213874 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 1000 ug/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (55150-364-01) / 1 mL in 1 VIAL, MULTI-DOSE
  • 10 VIAL, MULTI-DOSE in 1 CARTON (55150-364-10) / 1 mL in 1 VIAL, MULTI-DOSE
  • 25 VIAL, MULTI-DOSE in 1 CARTON (55150-364-25) / 1 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (3)

55150-364-01 1 VIAL, MULTI-DOSE in 1 CARTON (55150-364-01) / 1 mL in 1 VIAL, MULTI-DOSE 55150-364-10 10 VIAL, MULTI-DOSE in 1 CARTON (55150-364-10) / 1 mL in 1 VIAL, MULTI-DOSE 55150-364-25 25 VIAL, MULTI-DOSE in 1 CARTON (55150-364-25) / 1 mL in 1 VIAL, MULTI-DOSE

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"], "spl_id": "a0566c8d-7cb0-4ee7-8599-f2e8dc8992c7", "openfda": {"nui": ["M0022794", "N0000175951"], "upc": ["0355150364015", "0355150364107"], "unii": ["P6YC3EG204"], "rxcui": ["309594"], "spl_set_id": ["db84d0ea-5c15-47f5-bbe2-8d455e75695e"], "pharm_class_cs": ["Vitamin B 12 [CS]"], "pharm_class_epc": ["Vitamin B12 [EPC]"], "manufacturer_name": ["AuroMedics Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (55150-364-01)  / 1 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "55150-364-01", "marketing_start_date": "20201208"}, {"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (55150-364-10)  / 1 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "55150-364-10", "marketing_start_date": "20201208"}, {"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (55150-364-25)  / 1 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "55150-364-25", "marketing_start_date": "20201208"}], "brand_name": "Cyanocobalamin", "product_id": "55150-364_a0566c8d-7cb0-4ee7-8599-f2e8dc8992c7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Vitamin B 12 [CS]", "Vitamin B12 [EPC]"], "product_ndc": "55150-364", "generic_name": "Cyanocobalamin", "labeler_name": "AuroMedics Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyanocobalamin", "active_ingredients": [{"name": "CYANOCOBALAMIN", "strength": "1000 ug/mL"}], "application_number": "ANDA213874", "marketing_category": "ANDA", "marketing_start_date": "20201208", "listing_expiration_date": "20261231"}