galantamine

Generic: galantamine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name galantamine
Generic Name galantamine
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

galantamine hydrobromide 8 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-459
Product ID 65862-459_a5420811-7ce9-4ea6-8d93-6422f016b0d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090957
Listing Expiration 2026-12-31
Marketing Start 2011-03-29

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862459
Hyphenated Format 65862-459

Supplemental Identifiers

RxCUI
310436 310437 579148
UPC
0365862460608
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 (source: ndc)
Generic Name galantamine (source: ndc)
Application Number ANDA090957 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (65862-459-60)
  • 7000 TABLET, FILM COATED in 1 BOTTLE (65862-459-71)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-459-99)
source: ndc

Packages (3)

65862-459-60 60 TABLET, FILM COATED in 1 BOTTLE (65862-459-60) 65862-459-71 7000 TABLET, FILM COATED in 1 BOTTLE (65862-459-71) 65862-459-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-459-99)

Ingredients (1)

galantamine hydrobromide (8 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": "a5420811-7ce9-4ea6-8d93-6422f016b0d8", "openfda": {"upc": ["0365862460608"], "unii": ["MJ4PTD2VVW"], "rxcui": ["310436", "310437", "579148"], "spl_set_id": ["4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (65862-459-60)", "package_ndc": "65862-459-60", "marketing_start_date": "20110329"}, {"sample": false, "description": "7000 TABLET, FILM COATED in 1 BOTTLE (65862-459-71)", "package_ndc": "65862-459-71", "marketing_start_date": "20110329"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-459-99)", "package_ndc": "65862-459-99", "marketing_start_date": "20110329"}], "brand_name": "Galantamine", "product_id": "65862-459_a5420811-7ce9-4ea6-8d93-6422f016b0d8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "65862-459", "generic_name": "Galantamine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Galantamine", "active_ingredients": [{"name": "GALANTAMINE HYDROBROMIDE", "strength": "8 mg/1"}], "application_number": "ANDA090957", "marketing_category": "ANDA", "marketing_start_date": "20110329", "listing_expiration_date": "20261231"}