Galantamine Hydrobromide

Orange BookUNIISPLATC N06DA04

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN06DA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6362923651
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2365-1)

Annotations

UNII (FDA Substance ID)

MJ4PTD2VVW

GALANTAMINE HYDROBROMIDE

RxCUI 860693

Orange Book

A090178

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": "63629-2365_1f5f7a01-fa97-4448-b3a2-755e8271cbeb",
  "productndc": "63629-2365",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "090178",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "001",
        "approval_date": "Feb 2, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 16MG BASE",
        "product_no": "002",
        "approval_date": "Feb 2, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 24MG BASE",
        "product_no": "003",
        "approval_date": "Feb 2, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GALANTAMINE HYDROBROMIDE",
  "proprietary_name": "Galantamine Hydrobromide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090178",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Galantamine Hydrobromide",
  "start_marketing_date": "20110209",
  "active_numerator_strength": "16"
}

Related drugs

Other records sharing ATC code N06DA04.

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