🇺🇸
United States · US · US:69607-1970_53818277-b127-4271-9604-8015eacd6c99
Ibuprofen PM
Orange BookUNIISPLATC D04AA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWR Group, Inc.
CountryUS (United States)
ATC codeD04AA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169607197011 BOTTLE, PLASTIC in 1 BOX (69607-1970-1) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
4OD433S209
DIPHENHYDRAMINE CITRATE
RxCUI 82004
Orange Book
A211404
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4OD433S209",
"rxcui": "82004",
"inchikey": "SPCKHVPPRJWQRZ-UHFFFAOYSA-N",
"display_name": "DIPHENHYDRAMINE CITRATE",
"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": "69607-1970_53818277-b127-4271-9604-8015eacd6c99",
"productndc": "69607-1970",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "211404",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "38MG;200MG",
"product_no": "001",
"approval_date": "Apr 11, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
"proprietary_name": "Ibuprofen PM",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA211404",
"marketing_category": "ANDA",
"nonproprietary_name": "Diphenhydramine Citrate, Ibuprofen",
"start_marketing_date": "20250228",
"active_numerator_strength": "38; 200"
}Related drugs
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