cyanokit

Generic: hydroxocobalamin

Labeler: btg international inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyanokit
Generic Name hydroxocobalamin
Labeler btg international inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

hydroxocobalamin 5 g/250mL

Manufacturer
BTG INTERNATIONAL INC.

Identifiers & Regulatory

Product NDC 50633-310
Product ID 50633-310_9955075c-c059-4b63-b387-e98ef13e60dc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022041
Listing Expiration 2026-12-31
Marketing Start 2021-12-15

Pharmacologic Class

Established (EPC)
antidote [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50633310
Hyphenated Format 50633-310

Supplemental Identifiers

RxCUI
700496 700499
UNII
Q40X8H422O
NUI
N0000175429

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 cyanokit (source: ndc)
Generic Name hydroxocobalamin (source: ndc)
Application Number NDA022041 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 5 g/250mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (50633-310-11) / 250 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

50633-310-11 1 VIAL, GLASS in 1 CARTON (50633-310-11) / 250 mL in 1 VIAL, GLASS

Ingredients (1)

hydroxocobalamin (5 g/250mL)

Linked Drug Pages (1)

Cyanokit ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9955075c-c059-4b63-b387-e98ef13e60dc", "openfda": {"nui": ["N0000175429"], "unii": ["Q40X8H422O"], "rxcui": ["700496", "700499"], "spl_set_id": ["d56fcc8d-bd64-46ab-b0c0-2124bd745a6b"], "pharm_class_epc": ["Antidote [EPC]"], "manufacturer_name": ["BTG INTERNATIONAL INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (50633-310-11)  / 250 mL in 1 VIAL, GLASS", "package_ndc": "50633-310-11", "marketing_start_date": "20211215"}], "brand_name": "Cyanokit", "product_id": "50633-310_9955075c-c059-4b63-b387-e98ef13e60dc", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Antidote [EPC]"], "product_ndc": "50633-310", "generic_name": "Hydroxocobalamin", "labeler_name": "BTG INTERNATIONAL INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyanokit", "active_ingredients": [{"name": "HYDROXOCOBALAMIN", "strength": "5 g/250mL"}], "application_number": "NDA022041", "marketing_category": "NDA", "marketing_start_date": "20211215", "listing_expiration_date": "20261231"}