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United States · US · US:85766-191_4d82198d-9843-808b-e063-6394a90a5097

Cephalexin

Orange BookUNIISPLATC J01DB01

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

Identification

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

Packs · 6

  • ndc11
    8576619114
    14 CAPSULE in 1 BOTTLE, PLASTIC (85766-191-14)
  • ndc11
    8576619120
    20 CAPSULE in 1 BOTTLE, PLASTIC (85766-191-20)
  • ndc11
    8576619121
    21 CAPSULE in 1 BOTTLE, PLASTIC (85766-191-21)
  • ndc11
    8576619128
    28 CAPSULE in 1 BOTTLE, PLASTIC (85766-191-28)
  • ndc11
    8576619130
    30 CAPSULE in 1 BOTTLE, PLASTIC (85766-191-30)
  • ndc11
    8576619133
    30 CAPSULE in 1 BLISTER PACK (85766-191-33)

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": "85766-191_4d82198d-9843-808b-e063-6394a90a5097",
  "productndc": "85766-191",
  "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": "20210329",
  "active_numerator_strength": "500"
}

Related drugs

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