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United States · US · US:17856-0093_3b3e31b5-ced7-b373-e063-6294a90a16b2

Amantadine Hydrochloride

In shortageOrange BookUNIISPLATC N04BB01

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

Identification

ManufacturerATLANTIC BIOLOGICALS CORP.
CountryUS (United States)
ATC codeN04BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
M6Q1EO9TD0
AMANTADINE HYDROCHLORIDE
RxCUI 282415
Orange Book
A075060
AA
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": "17856-0093_3b3e31b5-ced7-b373-e063-6294a90a16b2",
  "productndc": "17856-0093",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "075060",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "50MG/5ML",
        "product_no": "001",
        "approval_date": "Dec 24, 1998"
      }
    ],
    "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": "ANDA075060",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AMANTADINE HYDROCHLORIDE",
  "start_marketing_date": "19981224",
  "active_numerator_strength": "50"
}

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