Cephalexin

Orange BookUNIISPLATC J01DB01

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeJ01DB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
6318704606
6 CAPSULE in 1 BOTTLE (63187-046-06)
ndc11
6318704614
14 CAPSULE in 1 BOTTLE (63187-046-14)
ndc11
6318704615
15 CAPSULE in 1 BOTTLE (63187-046-15)
ndc11
6318704620
20 CAPSULE in 1 BOTTLE (63187-046-20)
ndc11
6318704621
21 CAPSULE in 1 BOTTLE (63187-046-21)
ndc11
6318704628
28 CAPSULE in 1 BOTTLE (63187-046-28)
ndc11
6318704630
30 CAPSULE in 1 BOTTLE (63187-046-30)
ndc11
6318704640
40 CAPSULE in 1 BOTTLE (63187-046-40)

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": "63187-046_8202b9f1-6f03-4f64-a300-062d1679d0e8",
  "productndc": "63187-046",
  "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": "20060111",
  "active_numerator_strength": "500"
}

Related drugs

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