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United States · US · US:71335-3121_00e9051f-6b68-4770-9007-e9fb67a8da38

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
    7133531210
    21 TABLET, FILM COATED in 1 BOTTLE (71335-3121-0)
  • ndc11
    7133531211
    20 TABLET, FILM COATED in 1 BOTTLE (71335-3121-1)
  • ndc11
    7133531212
    15 TABLET, FILM COATED in 1 BOTTLE (71335-3121-2)
  • ndc11
    7133531213
    30 TABLET, FILM COATED in 1 BOTTLE (71335-3121-3)
  • ndc11
    7133531214
    40 TABLET, FILM COATED in 1 BOTTLE (71335-3121-4)
  • ndc11
    7133531215
    60 TABLET, FILM COATED in 1 BOTTLE (71335-3121-5)
  • ndc11
    7133531216
    90 TABLET, FILM COATED in 1 BOTTLE (71335-3121-6)
  • ndc11
    7133531217
    120 TABLET, FILM COATED in 1 BOTTLE (71335-3121-7)
  • ndc11
    7133531218
    50 TABLET, FILM COATED in 1 BOTTLE (71335-3121-8)
  • ndc11
    7133531219
    100 TABLET, FILM COATED in 1 BOTTLE (71335-3121-9)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A202413
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": "71335-3121_00e9051f-6b68-4770-9007-e9fb67a8da38",
  "productndc": "71335-3121",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202413",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Nov 23, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Nov 23, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "Nov 23, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Jul 5, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202413",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20240523",
  "active_numerator_strength": "600"
}

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