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United States · US · US:65162-770_7eec8df5-4a15-47be-9031-3e046204d452

Ibuprofen Pain Reliever/Fever Reducer

Orange BookUNIISPLATC G02CC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6516277002
    1 BOTTLE in 1 CARTON (65162-770-02) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • ndc11
    6516277011
    1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-770-11)
  • ndc11
    6516277050
    500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-770-50)
  • ndc11
    6516277069
    1 BOTTLE in 1 CARTON (65162-770-69) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A202300
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": "65162-770_7eec8df5-4a15-47be-9031-3e046204d452",
  "productndc": "65162-770",
  "dosage_form": "CAPSULE, LIQUID FILLED",
  "orange_book": {
    "appl_no": "202300",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 200MG FREE ACID AND POTASSIUM SALT",
        "product_no": "001",
        "approval_date": "Dec 23, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen Pain Reliever/Fever Reducer",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202300",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20111223",
  "active_numerator_strength": "200"
}

Related drugs

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