cyanocobalamin

Generic: cyanocobalamin

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

Drug Facts

Product Profile

Brand Name cyanocobalamin
Generic Name cyanocobalamin
Labeler lupin pharmaceuticals,inc.
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

cyanocobalamin 500 ug/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-237
Product ID 43386-237_bb7b94e1-b5cd-486f-9e34-38fc9595547a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210629
Listing Expiration 2026-12-31
Marketing Start 2024-01-29

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 43386237
Hyphenated Format 43386-237

Supplemental Identifiers

RxCUI
861113
UPC
0343386237609
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 ANDA210629 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 500 ug/1
source: ndc
Packaging
  • 1 CARTON in 1 BLISTER PACK (43386-237-60) / 4 SPRAY, METERED in 1 CARTON (43386-237-70)
source: ndc

Packages (1)

Ingredients (1)

cyanocobalamin (500 ug/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["NASAL"], "spl_id": "bb7b94e1-b5cd-486f-9e34-38fc9595547a", "openfda": {"nui": ["M0022794", "N0000175951"], "upc": ["0343386237609"], "unii": ["P6YC3EG204"], "rxcui": ["861113"], "spl_set_id": ["efb7dc02-f0c9-4537-9e23-b641c428068c"], "pharm_class_cs": ["Vitamin B 12 [CS]"], "pharm_class_epc": ["Vitamin B12 [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CARTON in 1 BLISTER PACK (43386-237-60)  / 4 SPRAY, METERED in 1 CARTON (43386-237-70)", "package_ndc": "43386-237-60", "marketing_start_date": "20240129"}], "brand_name": "Cyanocobalamin", "product_id": "43386-237_bb7b94e1-b5cd-486f-9e34-38fc9595547a", "dosage_form": "SPRAY, METERED", "pharm_class": ["Vitamin B 12 [CS]", "Vitamin B12 [EPC]"], "product_ndc": "43386-237", "generic_name": "Cyanocobalamin", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyanocobalamin", "active_ingredients": [{"name": "CYANOCOBALAMIN", "strength": "500 ug/1"}], "application_number": "ANDA210629", "marketing_category": "ANDA", "marketing_start_date": "20240129", "listing_expiration_date": "20261231"}