Ibuprofen

Orange BookUNIISPLATC G02CC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAurohealth LLC

CountryUS (United States)

ATC codeG02CC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 22

ndc11
5860270801
1 BOTTLE, PLASTIC in 1 CARTON (58602-708-01) / 24 TABLET in 1 BOTTLE, PLASTIC
ndc11
5860270802
1 BOTTLE, PLASTIC in 1 CARTON (58602-708-02) / 100 TABLET in 1 BOTTLE, PLASTIC
ndc11
5860270803
1 BOTTLE, PLASTIC in 1 CARTON (58602-708-03) / 150 TABLET in 1 BOTTLE, PLASTIC
ndc11
5860270804
200 TABLET in 1 BOTTLE, PLASTIC (58602-708-04)
ndc11
5860270805
1 BOTTLE, PLASTIC in 1 CARTON (58602-708-05) / 40 TABLET in 1 BOTTLE, PLASTIC
ndc11
5860270806
1 BOTTLE, PLASTIC in 1 CARTON (58602-708-06) / 90 TABLET in 1 BOTTLE, PLASTIC
ndc11
5860270807
1 BOTTLE in 1 CARTON (58602-708-07) / 100 TABLET in 1 BOTTLE
ndc11
5860270808
1 BOTTLE, PLASTIC in 1 CARTON (58602-708-08) / 50 TABLET in 1 BOTTLE, PLASTIC
ndc11
5860270809
1 BOTTLE in 1 CARTON (58602-708-09) / 50 TABLET in 1 BOTTLE
ndc11
5860270815
1 BOTTLE, PLASTIC in 1 CARTON (58602-708-15) / 60 TABLET in 1 BOTTLE, PLASTIC
ndc11
5860270817
1000 TABLET in 1 BOTTLE (58602-708-17)
ndc11
5860270836
250 TABLET in 1 BOTTLE, PLASTIC (58602-708-36)
ndc11
5860270840
500 TABLET in 1 BOTTLE (58602-708-40)
ndc11
5860270841
1000 TABLET in 1 BOTTLE, PLASTIC (58602-708-41)
ndc11
5860270849
300 TABLET in 1 BOTTLE (58602-708-49)
ndc11
5860270852
700 TABLET in 1 BOTTLE, PLASTIC (58602-708-52)
ndc11
5860270853
1 BOTTLE in 1 CARTON (58602-708-53) / 150 TABLET in 1 BOTTLE
ndc11
5860270873
1 BOTTLE in 1 CARTON (58602-708-73) / 24 TABLET in 1 BOTTLE
ndc11
5860270875
300 TABLET in 1 BOTTLE, PLASTIC (58602-708-75)
ndc11
5860270879
500 TABLET in 1 BOTTLE, PLASTIC (58602-708-79)
ndc11
5860270883
1 BOTTLE in 1 CARTON (58602-708-83) / 200 TABLET in 1 BOTTLE
ndc11
5860270887
550 TABLET in 1 BOTTLE, PLASTIC (58602-708-87)

Annotations

UNII (FDA Substance ID)

WK2XYI10QM

IBUPROFEN

RxCUI 5640

Orange Book

A208865

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": "58602-708_11f92293-edbc-4fce-a942-afeda4efa92a",
  "productndc": "58602-708",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208865",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Nov 8, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208865",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20220322",
  "active_numerator_strength": "200"
}

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