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 · 30

ndc11
5860271359
225 TABLET in 1 BOTTLE (58602-713-59)
ndc11
5860271363
550 TABLET in 1 BOTTLE (58602-713-63)
ndc11
5860271301
1 BOTTLE, PLASTIC in 1 CARTON (58602-713-01) / 24 TABLET in 1 BOTTLE, PLASTIC
ndc11
5860271302
1 BOTTLE, PLASTIC in 1 CARTON (58602-713-02) / 100 TABLET in 1 BOTTLE, PLASTIC
ndc11
5860271303
1 BOTTLE, PLASTIC in 1 CARTON (58602-713-03) / 150 TABLET in 1 BOTTLE, PLASTIC
ndc11
5860271305
1 BOTTLE, PLASTIC in 1 CARTON (58602-713-05) / 40 TABLET in 1 BOTTLE, PLASTIC
ndc11
5860271306
1 BOTTLE, PLASTIC in 1 CARTON (58602-713-06) / 90 TABLET in 1 BOTTLE, PLASTIC
ndc11
5860271307
1 BOTTLE in 1 CARTON (58602-713-07) / 100 TABLET in 1 BOTTLE
ndc11
5860271308
1 BOTTLE, PLASTIC in 1 CARTON (58602-713-08) / 50 TABLET in 1 BOTTLE, PLASTIC
ndc11
5860271309
1 BOTTLE in 1 CARTON (58602-713-09) / 50 TABLET in 1 BOTTLE
ndc11
5860271310
1 BOTTLE in 1 CARTON (58602-713-10) / 60 TABLET in 1 BOTTLE
ndc11
5860271315
1 BOTTLE, PLASTIC in 1 CARTON (58602-713-15) / 60 TABLET in 1 BOTTLE, PLASTIC
ndc11
5860271334
200 TABLET in 1 BOTTLE, PLASTIC (58602-713-34)
ndc11
5860271336
250 TABLET in 1 BOTTLE, PLASTIC (58602-713-36)
ndc11
5860271340
500 TABLET in 1 BOTTLE, PLASTIC (58602-713-40)
ndc11
5860271341
1000 TABLET in 1 BOTTLE, PLASTIC (58602-713-41)
ndc11
5860271345
1500 TABLET in 1 BOTTLE (58602-713-45)
ndc11
5860271348
500 TABLET in 1 BOTTLE (58602-713-48)
ndc11
5860271349
300 TABLET in 1 BOTTLE (58602-713-49)
ndc11
5860271352
700 TABLET in 1 BOTTLE, PLASTIC (58602-713-52)
ndc11
5860271353
1 BOTTLE in 1 CARTON (58602-713-53) / 150 TABLET in 1 BOTTLE
ndc11
5860271356
1 BOTTLE in 1 CARTON (58602-713-56) / 90 TABLET in 1 BOTTLE
ndc11
5860271357
1 BOTTLE in 1 CARTON (58602-713-57) / 40 TABLET in 1 BOTTLE
ndc11
5860271358
1000 TABLET in 1 BOTTLE (58602-713-58)
ndc11
5860271371
250 TABLET in 1 BOTTLE (58602-713-71)
ndc11
5860271373
1 BOTTLE in 1 CARTON (58602-713-73) / 24 TABLET in 1 BOTTLE
ndc11
5860271375
300 TABLET in 1 BOTTLE, PLASTIC (58602-713-75)
ndc11
5860271383
1 BOTTLE in 1 CARTON (58602-713-83) / 200 TABLET in 1 BOTTLE
ndc11
5860271386
750 TABLET in 1 BOTTLE (58602-713-86)
ndc11
5860271387
550 TABLET in 1 BOTTLE, PLASTIC (58602-713-87)

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": "58602-713_1100648c-6b9f-49c9-94d0-c40f24fe5c27",
  "productndc": "58602-713",
  "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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