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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 210676


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NDA 210676 describes IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, and Onesource Specialty, and is included in three NDAs. It is available from fourteen suppliers. Additional details are available on the IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE profile page.

The generic ingredient in IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride; ibuprofen. There are twenty-three drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; ibuprofen profile page.
Summary for 210676
Tradename:IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:diphenhydramine hydrochloride; ibuprofen
Patents:0
Pharmacology for NDA: 210676
Mechanism of ActionCyclooxygenase Inhibitors
Histamine H1 Receptor Antagonists
Suppliers and Packaging for NDA: 210676
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 210676 ANDA Aurohealth LLC 58602-717 58602-717-30 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-717-30)
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 210676 ANDA Aurohealth LLC 58602-814 58602-814-10 1 BOTTLE in 1 CARTON (58602-814-10) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrength25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date:Feb 14, 2019TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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