Galantamine

Orange BookUNIISPLATC N06DA04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerUpsher-Smith Laboratories, LLC

CountryUS (United States)

ATC codeN06DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2497972204
60 TABLET, FILM COATED in 1 BOTTLE (24979-722-04)

Annotations

UNII (FDA Substance ID)

MJ4PTD2VVW

GALANTAMINE HYDROBROMIDE

RxCUI 860693

Orange Book

A077604

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "MJ4PTD2VVW",
    "rxcui": "860693",
    "inchikey": "QORVDGQLPPAFRS-XPSHAMGMSA-N",
    "display_name": "GALANTAMINE HYDROBROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "18fd8860-d9ab-1b17-e063-6294a90aad9a": {
      "match": "brand_token",
      "title": "GALANTAMINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "5",
      "published_date": "2026-02-06"
    }
  },
  "productid": "24979-722_533bf2e6-a2ef-13d6-e063-6394a90ad6d4",
  "productndc": "24979-722",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077604",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Feb 6, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "002",
        "approval_date": "Feb 6, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12MG BASE",
        "product_no": "003",
        "approval_date": "Feb 6, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GALANTAMINE HYDROBROMIDE",
  "proprietary_name": "Galantamine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077604",
  "marketing_category": "ANDA",
  "nonproprietary_name": "galantamine",
  "start_marketing_date": "20240306",
  "active_numerator_strength": "4"
}

Related drugs

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