Galantamine

Orange BookUNIISPLATC N06DA04

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeN06DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6586246049
4000 TABLET, FILM COATED in 1 BOTTLE (65862-460-49)
ndc11
6586246060
60 TABLET, FILM COATED in 1 BOTTLE (65862-460-60)
ndc11
6586246099
1000 TABLET, FILM COATED in 1 BOTTLE (65862-460-99)

Annotations

UNII (FDA Substance ID)

MJ4PTD2VVW

GALANTAMINE HYDROBROMIDE

RxCUI 860693

Orange Book

A090957

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": "65862-460_a5420811-7ce9-4ea6-8d93-6422f016b0d8",
  "productndc": "65862-460",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090957",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Mar 29, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "002",
        "approval_date": "Mar 29, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 12MG BASE",
        "product_no": "003",
        "approval_date": "Mar 29, 2011"
      }
    ],
    "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": "ANDA090957",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Galantamine",
  "start_marketing_date": "20110329",
  "active_numerator_strength": "12"
}

Related drugs

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