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United States · US · US:46708-586_1ca812f6-6983-4d9a-b08e-a8f7e50054b8

Amantadine

In shortageOrange BookUNIISPLATC N04BB01

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

Identification

ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeN04BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4670858631
    100 TABLET in 1 BOTTLE (46708-586-31)
  • ndc11
    4670858671
    500 TABLET in 1 BOTTLE (46708-586-71)

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 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": "46708-586_1ca812f6-6983-4d9a-b08e-a8f7e50054b8",
  "productndc": "46708-586",
  "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 Capsule",
  "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"
}

Related drugs

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