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United States · US · US:72189-657_487125c0-51e8-aea3-e063-6394a90a6930

Amantadine HCL

In shortageOrange BookUNIISPLATC N04BB01

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

Identification

ManufacturerDirect RX
CountryUS (United States)
ATC codeN04BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7218965730
    30 CAPSULE in 1 BOTTLE (72189-657-30)

Annotations

UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A210129
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": "72189-657_487125c0-51e8-aea3-e063-6394a90a6930",
  "productndc": "72189-657",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210129",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Mar 2, 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 HCL",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210129",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amantadine HCL",
  "start_marketing_date": "20260115",
  "active_numerator_strength": "100"
}

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