Galantamine Hydrobromide

Orange BookUNIISPLATC N06DA04

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN06DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054013749
100 mL in 1 BOTTLE (0054-0137-49)

Annotations

UNII (FDA Substance ID)

MJ4PTD2VVW

GALANTAMINE HYDROBROMIDE

RxCUI 860693

Orange Book

A078185

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": "0054-0137_b2bf3efc-7521-4ff7-b77c-6e312e34b3c4",
  "productndc": "0054-0137",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "078185",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "4MG/ML",
        "product_no": "001",
        "approval_date": "Jan 30, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GALANTAMINE HYDROBROMIDE",
  "proprietary_name": "Galantamine Hydrobromide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078185",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Galantamine Hydrobromide",
  "start_marketing_date": "20090814",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code N06DA04.

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