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United States · US · US:0591-4920_67ce5a52-d507-4333-b0a0-b7177f896aec

Amantadine Hydrochloride

In shortageOrange BookUNIISPLATC N04BB01

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeN04BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0591492001
    100 TABLET in 1 BOTTLE (0591-4920-01)

Annotations

UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A208096
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amantadine Hydrochloride Capsule
Raw payload (JSON)
{
  "unii": {
    "unii": "M6Q1EO9TD0",
    "rxcui": "282415",
    "inchikey": "WOLHOYHSEKDWQH-UHFFFAOYSA-N",
    "display_name": "AMANTADINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "da693bb0-0cc8-485d-89a7-c8cf28d440f3": {
      "match": "brand_token",
      "title": "AMANTADINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]",
      "spl_version": "8",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0591-4920_67ce5a52-d507-4333-b0a0-b7177f896aec",
  "productndc": "0591-4920",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208096",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 15, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMANTADINE HYDROCHLORIDE",
  "shortage_reason": "Amantadine Hydrochloride Capsule",
  "shortage_status": "current",
  "proprietary_name": "Amantadine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208096",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amantadine Hydrochloride",
  "start_marketing_date": "20170103",
  "active_numerator_strength": "100"
}

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