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United States · US · US:0054-1100_7b8f0ddb-00fd-4c22-afae-afe636f95f3a

Aminocaproic Acid

Orange BookUNIISPLATC B02AA01

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

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
    0054110058
    236.5 mL in 1 BOTTLE, PLASTIC (0054-1100-58)

Annotations

UNII (FDA Substance ID)
U6F3787206
AMINOCAPROIC ACID
RxCUI 99
Orange Book
N015230
AA
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": "0054-1100_7b8f0ddb-00fd-4c22-afae-afe636f95f3a",
  "productndc": "0054-1100",
  "dosage_form": "SYRUP",
  "orange_book": {
    "appl_no": "015230",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AA",
        "strength": "0.25GM/ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMINOCAPROIC ACID",
  "proprietary_name": "Aminocaproic Acid",
  "active_ingred_unit": "g/mL",
  "application_number": "NDA015230",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Aminocaproic Acid",
  "start_marketing_date": "20190312",
  "active_numerator_strength": ".25"
}

Related drugs

Other records sharing ATC code B02AA01.

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