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United States · US · US:76420-846_2195e546-9f39-0130-e063-6294a90ad9c3
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc117642084601100 TABLET, FILM COATED in 1 BOTTLE (76420-846-01)
- ndc117642084605500 TABLET, FILM COATED in 1 BOTTLE (76420-846-05)
- ndc11764208463030 TABLET, FILM COATED in 1 BOTTLE (76420-846-30)
- ndc11764208466060 TABLET, FILM COATED in 1 BOTTLE (76420-846-60)
- ndc11764208469090 TABLET, FILM COATED in 1 BOTTLE (76420-846-90)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A202413
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": "76420-846_2195e546-9f39-0130-e063-6294a90ad9c3",
"productndc": "76420-846",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202413",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Nov 23, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "002",
"approval_date": "Nov 23, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "003",
"approval_date": "Nov 23, 2016"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "300MG",
"product_no": "004",
"approval_date": "Jul 5, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202413",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20240523",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code G02CC01.
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