galantamine

Generic: galantamine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name galantamine
Generic Name galantamine
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

galantamine hydrobromide 4 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-729
Product ID 68084-729_2864c9b5-d581-daf1-e063-6394a90a2923
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090957
Listing Expiration 2026-12-31
Marketing Start 2014-07-03

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084729
Hyphenated Format 68084-729

Supplemental Identifiers

RxCUI
310436
UNII
MJ4PTD2VVW

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 (source: ndc)
Generic Name galantamine (source: ndc)
Application Number ANDA090957 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-729-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-729-11)
source: ndc

Packages (1)

68084-729-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-729-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-729-11)

Ingredients (1)

galantamine hydrobromide (4 mg/1)

Linked Drug Pages (1)

Galantamine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2864c9b5-d581-daf1-e063-6394a90a2923", "openfda": {"unii": ["MJ4PTD2VVW"], "rxcui": ["310436"], "spl_set_id": ["e80ec152-3616-4a13-9266-715550a8c398"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-729-21)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-729-11)", "package_ndc": "68084-729-21", "marketing_start_date": "20140703"}], "brand_name": "Galantamine", "product_id": "68084-729_2864c9b5-d581-daf1-e063-6394a90a2923", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "68084-729", "generic_name": "Galantamine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Galantamine", "active_ingredients": [{"name": "GALANTAMINE HYDROBROMIDE", "strength": "4 mg/1"}], "application_number": "ANDA090957", "marketing_category": "ANDA", "marketing_start_date": "20140703", "listing_expiration_date": "20261231"}