Amantadine Hydrochloride

In shortageOrange BookUNIISPLATC N04BB01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeN04BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7133525701
20 CAPSULE in 1 BOTTLE (71335-2570-1)
ndc11
7133525702
30 CAPSULE in 1 BOTTLE (71335-2570-2)
ndc11
7133525703
10 CAPSULE in 1 BOTTLE (71335-2570-3)
ndc11
7133525704
14 CAPSULE in 1 BOTTLE (71335-2570-4)
ndc11
7133525705
60 CAPSULE in 1 BOTTLE (71335-2570-5)
ndc11
7133525706
100 CAPSULE in 1 BOTTLE (71335-2570-6)

Annotations

UNII (FDA Substance ID)

M6Q1EO9TD0

AMANTADINE HYDROCHLORIDE

RxCUI 282415

Orange Book

A212044

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": "71335-2570_8518bc0c-9e98-4502-986d-5f75e8658aae",
  "productndc": "71335-2570",
  "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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