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United States · US · US:0093-4175_c75c0bb6-fe3e-43c6-bdde-edd904731795

Cephalexin

Orange BookUNIISPLATC J01DB01

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeJ01DB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0093417573
    100 mL in 1 BOTTLE (0093-4175-73)
  • ndc11
    0093417574
    200 mL in 1 BOTTLE (0093-4175-74)

Annotations

UNII (FDA Substance ID)
OBN7UDS42Y
CEPHALEXIN
RxCUI 215948
Orange Book
A062703
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "OBN7UDS42Y",
    "rxcui": "215948",
    "inchikey": "AVGYWQBCYZHHPN-CYJZLJNKSA-N",
    "display_name": "CEPHALEXIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "4ecf9314-76e2-c270-e063-6294a90ad8db": {
      "match": "brand_token",
      "title": "CEPHALEXIN CAPSULE [NORTHWIND HEALTH COMPANY, LLC]",
      "spl_version": "2",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0093-4175_c75c0bb6-fe3e-43c6-bdde-edd904731795",
  "productndc": "0093-4175",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "062703",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 125MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Feb 13, 1987"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE/5ML",
        "product_no": "002",
        "approval_date": "Feb 13, 1987"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEPHALEXIN",
  "proprietary_name": "Cephalexin",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA062703",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cephalexin",
  "start_marketing_date": "19900930",
  "active_numerator_strength": "125"
}

Related drugs

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