IBUPROFEN

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.

CountryUS (United States)

ATC codeG02CC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
6807133620
12 TABLET, FILM COATED in 1 BOTTLE (68071-3362-0)
ndc11
6807133621
21 TABLET, FILM COATED in 1 BOTTLE (68071-3362-1)
ndc11
6807133622
20 TABLET, FILM COATED in 1 BOTTLE (68071-3362-2)
ndc11
6807133623
30 TABLET, FILM COATED in 1 BOTTLE (68071-3362-3)
ndc11
6807133624
40 TABLET, FILM COATED in 1 BOTTLE (68071-3362-4)
ndc11
6807133625
15 TABLET, FILM COATED in 1 BOTTLE (68071-3362-5)
ndc11
6807133626
60 TABLET, FILM COATED in 1 BOTTLE (68071-3362-6)
ndc11
6807133629
90 TABLET, FILM COATED in 1 BOTTLE (68071-3362-9)

Annotations

UNII (FDA Substance ID)

WK2XYI10QM

IBUPROFEN

RxCUI 5640

Orange Book

A090796

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": "68071-3362_1ce905e8-9477-0b57-e063-6394a90ab525",
  "productndc": "68071-3362",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090796",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Dec 21, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Dec 21, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "Dec 21, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "IBUPROFEN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090796",
  "marketing_category": "ANDA",
  "nonproprietary_name": "IBUPROFEN",
  "start_marketing_date": "20151230",
  "active_numerator_strength": "800"
}

Related drugs

Other records sharing ATC code G02CC01.

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