amantadine hydrochloride

In shortageOrange BookUNIISPLATC N04BB01

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

Identification

ManufacturerZydus Lifesciences Limited

CountryUS (United States)

ATC codeN04BB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6584183501
100 CAPSULE in 1 BOTTLE (65841-835-01)
ndc11
6584183505
500 CAPSULE in 1 BOTTLE (65841-835-05)
ndc11
6584183506
30 CAPSULE in 1 BOTTLE (65841-835-06)
ndc11
6584183577
10 BLISTER PACK in 1 CARTON (65841-835-77) / 10 CAPSULE in 1 BLISTER PACK (65841-835-30)

Annotations

UNII (FDA Substance ID)

M6Q1EO9TD0

AMANTADINE HYDROCHLORIDE

RxCUI 282415

Orange Book

A208278

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": "65841-835_c3ccac09-f561-4d2e-ba15-7d6149086042",
  "productndc": "65841-835",
  "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 Tablet",
  "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

Other records sharing ATC code N04BB01.

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