galantamine hydrobromide

Generic: galantamine hydrobromide

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

Drug Facts

Product Profile

Brand Name galantamine hydrobromide
Generic Name galantamine hydrobromide
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

galantamine hydrobromide 4 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0137
Product ID 0054-0137_b2bf3efc-7521-4ff7-b77c-6e312e34b3c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078185
Listing Expiration 2026-12-31
Marketing Start 2009-08-14

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540137
Hyphenated Format 0054-0137

Supplemental Identifiers

RxCUI
860901
UNII
MJ4PTD2VVW

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 galantamine hydrobromide (source: ndc)
Generic Name galantamine hydrobromide (source: ndc)
Application Number ANDA078185 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (0054-0137-49)
source: ndc

Packages (1)

0054-0137-49 100 mL in 1 BOTTLE (0054-0137-49)

Ingredients (1)

galantamine hydrobromide (4 mg/mL)

Linked Drug Pages (1)

Galantamine Hydrobromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b2bf3efc-7521-4ff7-b77c-6e312e34b3c4", "openfda": {"unii": ["MJ4PTD2VVW"], "rxcui": ["860901"], "spl_set_id": ["d5b0e225-e94d-4324-afb2-b6e51c949dd0"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (0054-0137-49)", "package_ndc": "0054-0137-49", "marketing_start_date": "20090814"}], "brand_name": "Galantamine Hydrobromide", "product_id": "0054-0137_b2bf3efc-7521-4ff7-b77c-6e312e34b3c4", "dosage_form": "SOLUTION", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "0054-0137", "generic_name": "Galantamine Hydrobromide", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Galantamine Hydrobromide", "active_ingredients": [{"name": "GALANTAMINE HYDROBROMIDE", "strength": "4 mg/mL"}], "application_number": "ANDA078185", "marketing_category": "ANDA", "marketing_start_date": "20090814", "listing_expiration_date": "20261231"}