AMANTADINE HYDROCHLORIDE

In shortageOrange BookUNIISPLATC N04BB01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCardinal Health 107, LLC

CountryUS (United States)

ATC codeN04BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5515494445
5 CUP, UNIT-DOSE in 1 BAG (55154-9444-5) / 10 mL in 1 CUP, UNIT-DOSE

Annotations

UNII (FDA Substance ID)

M6Q1EO9TD0

AMANTADINE HYDROCHLORIDE

RxCUI 282415

Orange Book

A074509

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": "55154-9444_cd832f95-6827-4dfb-81e7-1c2fa406cb70",
  "productndc": "55154-9444",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "074509",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "50MG/5ML",
        "product_no": "001",
        "approval_date": "Jul 17, 1995"
      }
    ],
    "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/5mL",
  "application_number": "ANDA074509",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AMANTADINE HYDROCHLORIDE",
  "start_marketing_date": "19950717",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code N04BB01.

Access this data programmatically

Query AMANTADINE HYDROCHLORIDE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs