🇺🇸
United States · US · US:63868-829_f0d1d4c1-7214-b8c2-e053-2995a90a650f
Ibuprofen PM
Orange BookUNIISPLATC D04AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCHAIN DRUG MARKETING ASSOCIATION INC.
CountryUS (United States)
ATC codeD04AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163868829401 BOTTLE, PLASTIC in 1 CARTON (63868-829-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A090397
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "TC2D6JAD40",
"rxcui": "1362",
"inchikey": "PCHPORCSPXIHLZ-UHFFFAOYSA-N",
"display_name": "DIPHENHYDRAMINE HYDROCHLORIDE",
"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": "63868-829_f0d1d4c1-7214-b8c2-e053-2995a90a650f",
"productndc": "63868-829",
"dosage_form": "CAPSULE, LIQUID FILLED",
"orange_book": {
"appl_no": "090397",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "25MG;EQ 200MG FREE ACID AND POTASSIUM SALT",
"product_no": "001",
"approval_date": "Nov 22, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN",
"proprietary_name": "Ibuprofen PM",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA090397",
"marketing_category": "ANDA",
"nonproprietary_name": "IBUPROFEN, DIPHENHYDRAMINE HCL",
"start_marketing_date": "20210611",
"active_numerator_strength": "25; 200"
}Related drugs
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