Aminocaproic Acid

Orange BookUNIISPLATC B02AA01

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeB02AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054111013
30 TABLET in 1 BOTTLE (0054-1110-13)

Annotations

UNII (FDA Substance ID)

U6F3787206

AMINOCAPROIC ACID

RxCUI 99

Orange Book

N015197

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "U6F3787206",
    "rxcui": "99",
    "inchikey": "SLXKOJJOQWFEFD-UHFFFAOYSA-N",
    "display_name": "AMINOCAPROIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4c2612ab-86a4-4c54-a5c0-e837f755965f": {
      "match": "brand_token",
      "title": "AMINOCAPROIC ACID TABLET [AMERICAN HEALTH PACKAGING]",
      "spl_version": "4",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0054-1110_7b8f0ddb-00fd-4c22-afae-afe636f95f3a",
  "productndc": "0054-1110",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "015197",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Jun 24, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMINOCAPROIC ACID",
  "proprietary_name": "Aminocaproic Acid",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA015197",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Aminocaproic Acid",
  "start_marketing_date": "20190312",
  "active_numerator_strength": "1000"
}

Related drugs

Other records sharing ATC code B02AA01.

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