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United States · US · US:70436-004_533c1fab-f502-439d-e063-6394a90a8c32

Galantamine

Orange BookUNIISPLATC N06DA04

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSlate Run Pharmaceuticals, LLC
CountryUS (United States)
ATC codeN06DA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7043600406
    60 TABLET, FILM COATED in 1 BOTTLE (70436-004-06)

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": "70436-004_533c1fab-f502-439d-e063-6394a90a8c32",
  "productndc": "70436-004",
  "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": "20170802",
  "active_numerator_strength": "4"
}

Related drugs

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