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United States · US · US:23155-362_fc8e4e42-8e97-41f0-aefc-2f01f65d8c6b

Amantadine Hydrochloride

In shortageOrange BookUNIISPLATC N04BB01

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN04BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2315536201
    100 CAPSULE in 1 BOTTLE (23155-362-01)
  • ndc11
    2315536203
    30 CAPSULE in 1 BOTTLE (23155-362-03)
  • ndc11
    2315536205
    500 CAPSULE in 1 BOTTLE (23155-362-05)

Annotations

UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A209171
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": "23155-362_fc8e4e42-8e97-41f0-aefc-2f01f65d8c6b",
  "productndc": "23155-362",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "209171",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jun 12, 2017"
      }
    ],
    "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 Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209171",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amantadine Hydrochloride",
  "start_marketing_date": "20170612",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N04BB01.

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