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United States · US · US:65162-356_53da63da-f301-44dc-902c-2c288304929f
Ibuprofen
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
- ndc1165162356021 BOTTLE in 1 CARTON (65162-356-02) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
- ndc1165162356111000 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-356-11)
- ndc116516235650500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-356-50)
- ndc1165162356691 BOTTLE in 1 CARTON (65162-356-69) / 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": "65162-356_53da63da-f301-44dc-902c-2c288304929f",
"productndc": "65162-356",
"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",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202300",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20130329",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G02CC01.
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