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United States · US · US:70010-068_5125d89b-4fd5-b823-e063-6394a90a1eff

Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerGranules Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    7001006801
    100 TABLET, FILM COATED in 1 BOTTLE (70010-068-01)
  • ndc11
    7001006803
    30 TABLET, FILM COATED in 1 BOTTLE (70010-068-03)
  • ndc11
    7001006805
    500 TABLET, FILM COATED in 1 BOTTLE (70010-068-05)
  • ndc11
    7001006810
    1000 TABLET, FILM COATED in 1 BOTTLE (70010-068-10)
  • ndc11
    7001006850
    50 TABLET, FILM COATED in 1 BOTTLE (70010-068-50)
  • ndc11
    7001006882
    9 BLISTER PACK in 1 CARTON (70010-068-82) / 14 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A091625
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WK2XYI10QM",
    "rxcui": "5640",
    "inchikey": "HEFNNWSXXWATRW-UHFFFAOYSA-N",
    "display_name": "IBUPROFEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "aeee629b-255c-40d8-8e95-779aec00f723": {
      "match": "brand_token",
      "title": "IBUPROFEN TABLET [NORTHSTAR RX LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "70010-068_5125d89b-4fd5-b823-e063-6394a90a1eff",
  "productndc": "70010-068",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091625",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Sep 15, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Sep 15, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "Sep 15, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091625",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20260218",
  "active_numerator_strength": "800"
}

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