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United States · US · US:72888-033_3982396f-63e5-ca93-e063-6394a90a75f2

Amantadine Hydrochloride

In shortageOrange BookUNIISPLATC N04BB01

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

Identification

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

Packs · 4

  • ndc11
    7288803300
    1000 CAPSULE in 1 BOTTLE (72888-033-00)
  • ndc11
    7288803301
    100 CAPSULE in 1 BOTTLE (72888-033-01)
  • ndc11
    7288803305
    500 CAPSULE in 1 BOTTLE (72888-033-05)
  • ndc11
    7288803330
    30 CAPSULE in 1 BOTTLE (72888-033-30)

Annotations

UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A212044
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": "72888-033_3982396f-63e5-ca93-e063-6394a90a75f2",
  "productndc": "72888-033",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "212044",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "May 21, 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 Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212044",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Amantadine Hydrochloride",
  "start_marketing_date": "20200521",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code N04BB01.

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