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United States · US · US:71335-1270_99ce22f5-0b6e-42f3-8807-66fbebfedfd3

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 · 9

  • ndc11
    7133512701
    20 TABLET, FILM COATED in 1 BOTTLE (71335-1270-1)
  • ndc11
    7133512702
    30 TABLET, FILM COATED in 1 BOTTLE (71335-1270-2)
  • ndc11
    7133512703
    40 TABLET, FILM COATED in 1 BOTTLE (71335-1270-3)
  • ndc11
    7133512704
    60 TABLET, FILM COATED in 1 BOTTLE (71335-1270-4)
  • ndc11
    7133512705
    90 TABLET, FILM COATED in 1 BOTTLE (71335-1270-5)
  • ndc11
    7133512706
    120 TABLET, FILM COATED in 1 BOTTLE (71335-1270-6)
  • ndc11
    7133512707
    100 TABLET, FILM COATED in 1 BOTTLE (71335-1270-7)
  • ndc11
    7133512708
    21 TABLET, FILM COATED in 1 BOTTLE (71335-1270-8)
  • ndc11
    7133512709
    15 TABLET, FILM COATED in 1 BOTTLE (71335-1270-9)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A078329
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": "71335-1270_99ce22f5-0b6e-42f3-8807-66fbebfedfd3",
  "productndc": "71335-1270",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078329",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Feb 5, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Feb 5, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "Feb 5, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078329",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20180824",
  "active_numerator_strength": "400"
}

Related drugs

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