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United States · US · US:71205-702_743d1b73-f47e-4bbf-bb52-45b1e7f17308

amantadine hydrochloride

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 · 4

  • ndc11
    7120570220
    20 CAPSULE in 1 BOTTLE (71205-702-20)
  • ndc11
    7120570230
    30 CAPSULE in 1 BOTTLE (71205-702-30)
  • ndc11
    7120570260
    60 CAPSULE in 1 BOTTLE (71205-702-60)
  • ndc11
    7120570290
    90 CAPSULE in 1 BOTTLE (71205-702-90)

Annotations

UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A208278
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": "71205-702_743d1b73-f47e-4bbf-bb52-45b1e7f17308",
  "productndc": "71205-702",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "208278",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "May 31, 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": "ANDA208278",
  "marketing_category": "ANDA",
  "nonproprietary_name": "amantadine hydrochloride",
  "start_marketing_date": "20160804",
  "active_numerator_strength": "100"
}

Related drugs

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