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 · 16

ndc11
5860280107
1 BOTTLE in 1 CARTON (58602-801-07) / 24 TABLET in 1 BOTTLE
ndc11
5860280112
1 BOTTLE in 1 CARTON (58602-801-12) / 40 TABLET in 1 BOTTLE
ndc11
5860280114
1 BOTTLE in 1 CARTON (58602-801-14) / 50 TABLET in 1 BOTTLE
ndc11
5860280115
1 BOTTLE in 1 CARTON (58602-801-15) / 60 TABLET in 1 BOTTLE
ndc11
5860280119
1 BOTTLE in 1 CARTON (58602-801-19) / 90 TABLET in 1 BOTTLE
ndc11
5860280121
1 BOTTLE in 1 CARTON (58602-801-21) / 100 TABLET in 1 BOTTLE
ndc11
5860280129
1 BOTTLE in 1 CARTON (58602-801-29) / 150 TABLET in 1 BOTTLE
ndc11
5860280134
1 BOTTLE in 1 CARTON (58602-801-34) / 200 TABLET in 1 BOTTLE
ndc11
5860280135
1 BOTTLE in 1 CARTON (58602-801-35) / 225 TABLET in 1 BOTTLE
ndc11
5860280136
1 BOTTLE in 1 CARTON (58602-801-36) / 250 TABLET in 1 BOTTLE
ndc11
5860280138
300 TABLET in 1 BOTTLE (58602-801-38)
ndc11
5860280140
500 TABLET in 1 BOTTLE (58602-801-40)
ndc11
5860280141
1000 TABLET in 1 BOTTLE (58602-801-41)
ndc11
5860280159
1500 TABLET in 1 BOTTLE (58602-801-59)
ndc11
5860280187
550 TABLET in 1 BOTTLE (58602-801-87)
ndc11
5860280188
750 TABLET in 1 BOTTLE (58602-801-88)

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": "58602-801_19309ddd-73dc-462a-afaa-899834a2d783",
  "productndc": "58602-801",
  "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": "20171108",
  "active_numerator_strength": "200"
}

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