galantamine

Generic: galantamine

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name galantamine
Generic Name galantamine
Labeler rising pharma holdings, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

galantamine hydrobromide 4 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-049
Product ID 57237-049_f59a93d6-9a01-40ad-a9ef-4eaacff23b79
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 57237049
Hyphenated Format 57237-049

Supplemental Identifiers

RxCUI
310436 310437 579148
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
  • 4 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (57237-049-60)
source: ndc

Packages (1)

57237-049-60 60 TABLET, FILM COATED in 1 BOTTLE (57237-049-60)

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": "f59a93d6-9a01-40ad-a9ef-4eaacff23b79", "openfda": {"unii": ["MJ4PTD2VVW"], "rxcui": ["310436", "310437", "579148"], "spl_set_id": ["a0dc1a93-b7b8-4179-8ea7-ceecbe1ef243"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (57237-049-60)", "package_ndc": "57237-049-60", "marketing_start_date": "20110329"}], "brand_name": "Galantamine", "product_id": "57237-049_f59a93d6-9a01-40ad-a9ef-4eaacff23b79", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]"], "product_ndc": "57237-049", "generic_name": "Galantamine", "labeler_name": "Rising Pharma Holdings, Inc.", "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": "20110329", "listing_expiration_date": "20261231"}