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United States · US · US:71335-1207_b4248cc8-1b23-44c3-8815-dac97370b01d

Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7133512070
    21 TABLET, FILM COATED in 1 BOTTLE (71335-1207-0)
  • ndc11
    7133512071
    20 TABLET, FILM COATED in 1 BOTTLE (71335-1207-1)
  • ndc11
    7133512072
    15 TABLET, FILM COATED in 1 BOTTLE (71335-1207-2)
  • ndc11
    7133512073
    30 TABLET, FILM COATED in 1 BOTTLE (71335-1207-3)
  • ndc11
    7133512074
    40 TABLET, FILM COATED in 1 BOTTLE (71335-1207-4)
  • ndc11
    7133512075
    60 TABLET, FILM COATED in 1 BOTTLE (71335-1207-5)
  • ndc11
    7133512076
    90 TABLET, FILM COATED in 1 BOTTLE (71335-1207-6)
  • ndc11
    7133512077
    120 TABLET, FILM COATED in 1 BOTTLE (71335-1207-7)
  • ndc11
    7133512078
    50 TABLET, FILM COATED in 1 BOTTLE (71335-1207-8)
  • ndc11
    7133512079
    100 TABLET, FILM COATED in 1 BOTTLE (71335-1207-9)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A078329
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": "71335-1207_b4248cc8-1b23-44c3-8815-dac97370b01d",
  "productndc": "71335-1207",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078329",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Feb 5, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Feb 5, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "Feb 5, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078329",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20180824",
  "active_numerator_strength": "600"
}

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