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United States · US · US:71335-1218_3018301b-f363-483b-bd7f-842bae77e2e7

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
    7133512180
    21 TABLET, FILM COATED in 1 BOTTLE (71335-1218-0)
  • ndc11
    7133512181
    20 TABLET, FILM COATED in 1 BOTTLE (71335-1218-1)
  • ndc11
    7133512182
    15 TABLET, FILM COATED in 1 BOTTLE (71335-1218-2)
  • ndc11
    7133512183
    30 TABLET, FILM COATED in 1 BOTTLE (71335-1218-3)
  • ndc11
    7133512184
    40 TABLET, FILM COATED in 1 BOTTLE (71335-1218-4)
  • ndc11
    7133512185
    60 TABLET, FILM COATED in 1 BOTTLE (71335-1218-5)
  • ndc11
    7133512186
    90 TABLET, FILM COATED in 1 BOTTLE (71335-1218-6)
  • ndc11
    7133512187
    120 TABLET, FILM COATED in 1 BOTTLE (71335-1218-7)
  • ndc11
    7133512188
    50 TABLET, FILM COATED in 1 BOTTLE (71335-1218-8)
  • ndc11
    7133512189
    100 TABLET, FILM COATED in 1 BOTTLE (71335-1218-9)

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": "71335-1218_3018301b-f363-483b-bd7f-842bae77e2e7",
  "productndc": "71335-1218",
  "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": "20151221",
  "active_numerator_strength": "600"
}

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