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United States · US · US:55111-684_a7977972-4353-9ca0-d419-e37039010e7d
IBU
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc115511168401100 TABLET in 1 BOTTLE (55111-684-01)
- ndc115511168405500 TABLET in 1 BOTTLE (55111-684-05)
- ndc11551116840990 TABLET in 1 BOTTLE (55111-684-09)
- ndc11551116843030 TABLET in 1 BOTTLE (55111-684-30)
- ndc11551116845050 TABLET in 1 BOTTLE (55111-684-50)
- ndc11551116846060 TABLET in 1 BOTTLE (55111-684-60)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A075682
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": {
"bbf4821d-f9fc-9f6e-e053-2a95a90a5253": {
"match": "brand_token",
"title": "IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
"spl_version": "6",
"published_date": "2026-04-29"
}
},
"productid": "55111-684_a7977972-4353-9ca0-d419-e37039010e7d",
"productndc": "55111-684",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075682",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Nov 14, 2001"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "002",
"approval_date": "Nov 14, 2001"
},
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "003",
"approval_date": "Nov 14, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "IBU",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075682",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20081120",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code G02CC01.
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