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United States · US · US:82804-267_7aa6bc18-1cee-4b6d-b7c3-0bac6a924ece

Amantadine

In shortageOrange BookUNIISPLATC N04BB01

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN04BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8280426720
    20 TABLET in 1 BOTTLE (82804-267-20)

Annotations

UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A214284
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amantadine Hydrochloride Tablet
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": "82804-267_7aa6bc18-1cee-4b6d-b7c3-0bac6a924ece",
  "productndc": "82804-267",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214284",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Oct 15, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMANTADINE HYDROCHLORIDE",
  "shortage_reason": "Amantadine Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Amantadine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214284",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amantadine",
  "start_marketing_date": "20201020",
  "active_numerator_strength": "100"
}

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