Cephalexin

Orange BookUNIISPLATC J01DB01

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeJ01DB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7642073600
100 CAPSULE in 1 BOX (76420-736-00)
ndc11
7642073601
1 CAPSULE in 1 POUCH (76420-736-01)
ndc11
7642073614
14 CAPSULE in 1 BOTTLE, PLASTIC (76420-736-14)
ndc11
7642073620
20 CAPSULE in 1 BOTTLE, PLASTIC (76420-736-20)
ndc11
7642073621
21 CAPSULE in 1 BOTTLE, PLASTIC (76420-736-21)
ndc11
7642073628
28 CAPSULE in 1 BOTTLE, PLASTIC (76420-736-28)
ndc11
7642073630
30 CAPSULE in 1 BOTTLE, PLASTIC (76420-736-30)
ndc11
7642073640
40 CAPSULE in 1 BOTTLE, PLASTIC (76420-736-40)

Annotations

UNII (FDA Substance ID)

OBN7UDS42Y

CEPHALEXIN

RxCUI 215948

Orange Book

A065229

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": "76420-736_1b62bc14-7a3a-dd94-e063-6294a90a84ba",
  "productndc": "76420-736",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065229",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Nov 25, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Nov 25, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEPHALEXIN",
  "proprietary_name": "Cephalexin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065229",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cephalexin",
  "start_marketing_date": "20210720",
  "active_numerator_strength": "500"
}

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