CEPHALEXIN

Orange BookUNIISPLATC J01DB01

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

Identification

ManufacturerDirect_Rx

CountryUS (United States)

ATC codeJ01DB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6191960630
30 CAPSULE in 1 BOTTLE (61919-606-30)

Annotations

UNII (FDA Substance ID)

OBN7UDS42Y

CEPHALEXIN

RxCUI 215948

Orange Book

A090836

ABABAB

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": "61919-606_4defe11f-63bb-f96c-e063-6294a90a6713",
  "productndc": "61919-606",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "090836",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Dec 20, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Dec 20, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 333MG BASE",
        "product_no": "003",
        "approval_date": "Mar 29, 2013"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 750MG BASE",
        "product_no": "004",
        "approval_date": "Mar 29, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEPHALEXIN",
  "proprietary_name": "CEPHALEXIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090836",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CEPHALEXIN",
  "start_marketing_date": "20190813",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J01DB01.

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