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United States · US · US:67877-220_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf

Cephalexin

Orange BookUNIISPLATC J01DB01

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

Identification

ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeJ01DB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    6787722001
    100 CAPSULE in 1 BOTTLE (67877-220-01)
  • ndc11
    6787722005
    500 CAPSULE in 1 BOTTLE (67877-220-05)
  • ndc11
    6787722010
    1000 CAPSULE in 1 BOTTLE (67877-220-10)
  • ndc11
    6787722020
    20 CAPSULE in 1 BOTTLE (67877-220-20)
  • ndc11
    6787722038
    100 BLISTER PACK in 1 CARTON (67877-220-38) / 1 CAPSULE in 1 BLISTER PACK
  • ndc11
    6787722074
    50 BLISTER PACK in 1 CARTON (67877-220-74) / 1 CAPSULE in 1 BLISTER PACK
  • ndc11
    6787722084
    30 BLISTER PACK in 1 CARTON (67877-220-84) / 1 CAPSULE in 1 BLISTER PACK

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": "67877-220_3e6d72ab-f4ea-4ca6-984d-e6de1b3e7fdf",
  "productndc": "67877-220",
  "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": "20110120",
  "active_numerator_strength": "250"
}

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