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United States · US · US:50090-5196_d53accce-79fa-48ff-ba91-88cbe796407d

Cephalexin

Orange BookUNIISPLATC J01DB01

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ01DB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009051960
    100 mL in 1 BOTTLE (50090-5196-0)

Annotations

UNII (FDA Substance ID)
OBN7UDS42Y
CEPHALEXIN
RxCUI 215948
Orange Book
A210221
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": "50090-5196_d53accce-79fa-48ff-ba91-88cbe796407d",
  "productndc": "50090-5196",
  "dosage_form": "FOR SUSPENSION",
  "orange_book": {
    "appl_no": "210221",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 125MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Mar 26, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE/5ML",
        "product_no": "002",
        "approval_date": "Mar 26, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEPHALEXIN",
  "proprietary_name": "Cephalexin",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA210221",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cephalexin",
  "start_marketing_date": "20190328",
  "active_numerator_strength": "250"
}

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