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United States · US · US:31722-008_5d30ffab-38a1-411d-94ad-0a15c227d882

Zafirlukast

Orange BookUNIISPLATC R03DC01

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR03DC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    3172200801
    10 BLISTER PACK in 1 CARTON (31722-008-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    3172200805
    500 TABLET, FILM COATED in 1 BOTTLE (31722-008-05)
  • ndc11
    3172200860
    60 TABLET, FILM COATED in 1 BOTTLE (31722-008-60)

Annotations

UNII (FDA Substance ID)
XZ629S5L50
ZAFIRLUKAST
RxCUI 114970
Orange Book
A212475
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "XZ629S5L50",
    "rxcui": "114970",
    "inchikey": "YEEZWCHGZNKEEK-UHFFFAOYSA-N",
    "display_name": "ZAFIRLUKAST",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "baba507f-6557-4551-815c-9ab6606e4ee1": {
      "match": "brand_token",
      "title": "ZAFIRLUKAST TABLET, COATED [STRIDES PHARMA SCIENCE LIMITED]",
      "spl_version": "7",
      "published_date": "2026-03-17"
    }
  },
  "productid": "31722-008_5d30ffab-38a1-411d-94ad-0a15c227d882",
  "productndc": "31722-008",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212475",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Sep 10, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Sep 10, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZAFIRLUKAST",
  "proprietary_name": "Zafirlukast",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212475",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zafirlukast",
  "start_marketing_date": "20200910",
  "active_numerator_strength": "20"
}

Related drugs

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