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United States · US · US:68788-8319_f854b253-22ef-4147-8608-d6c4f5446eb1

Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

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

Packs · 9

  • ndc11
    6878883191
    100 TABLET in 1 BOTTLE (68788-8319-1)
  • ndc11
    6878883192
    20 TABLET in 1 BOTTLE (68788-8319-2)
  • ndc11
    6878883193
    30 TABLET in 1 BOTTLE (68788-8319-3)
  • ndc11
    6878883194
    14 TABLET in 1 BOTTLE (68788-8319-4)
  • ndc11
    6878883195
    50 TABLET in 1 BOTTLE (68788-8319-5)
  • ndc11
    6878883196
    60 TABLET in 1 BOTTLE (68788-8319-6)
  • ndc11
    6878883197
    21 TABLET in 1 BOTTLE (68788-8319-7)
  • ndc11
    6878883198
    120 TABLET in 1 BOTTLE (68788-8319-8)
  • ndc11
    6878883199
    90 TABLET in 1 BOTTLE (68788-8319-9)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A213794
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": "68788-8319_f854b253-22ef-4147-8608-d6c4f5446eb1",
  "productndc": "68788-8319",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213794",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "May 8, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "May 8, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "May 8, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213794",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20221223",
  "active_numerator_strength": "800"
}

Related drugs

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