Cephalexin

Orange BookUNIISPLATC J01DB01

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeJ01DB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
5528905810
10 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-10)
ndc11
5528905814
14 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-14)
ndc11
5528905820
20 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-20)
ndc11
5528905828
28 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-28)
ndc11
5528905830
30 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-30)
ndc11
5528905840
40 CAPSULE in 1 BOTTLE, PLASTIC (55289-058-40)

Annotations

UNII (FDA Substance ID)

OBN7UDS42Y

CEPHALEXIN

RxCUI 215948

Orange Book

A062702

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": "55289-058_4304de4b-4197-e324-e063-6394a90ad3d4",
  "productndc": "55289-058",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "062702",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Feb 13, 1987"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "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/1",
  "application_number": "ANDA062702",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cephalexin",
  "start_marketing_date": "19900930",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J01DB01.

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