Last Updated: April 29, 2026

Details for New Drug Application (NDA): 216749

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NDA 216749 describes OXCARBAZEPINE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Aucta, Biocon Pharma, Bionpharma, Chartwell Rx, Hetero Labs Ltd Iii, Hikma, Kanchan Hlthcare, Macleods Pharms Ltd, Pai Holdings, Rubicon Research, Steranco Hlthcare, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Apotex, Aurobindo Pharma Ltd, Riconpharma Llc, Ani Pharms, Annora Pharma, Breckenridge Pharm, Epic Pharma Llc, Glenmark Pharms Ltd, Jubilant Cadista, Sun Pharm Inds, Taro, and Zydus, and is included in thirty NDAs. It is available from thirty-nine suppliers. Additional details are available on the OXCARBAZEPINE profile page.

The generic ingredient in OXCARBAZEPINE is oxcarbazepine. There are twenty-one drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Summary for 216749

Tradename:	OXCARBAZEPINE
Applicant:	Hetero Labs Ltd Iii
Ingredient:	oxcarbazepine
Patents:	0

Pharmacology for NDA: 216749

Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Suppliers and Packaging for NDA: 216749

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	216749	ANDA	Camber Pharmaceuticals, Inc.	31722-687	31722-687-25	1 BOTTLE in 1 CARTON (31722-687-25) / 250 mL in 1 BOTTLE
OXCARBAZEPINE	oxcarbazepine	SUSPENSION;ORAL	216749	ANDA	NorthStar RxLLC	72603-252	72603-252-01	1 BOTTLE in 1 CARTON (72603-252-01) / 250 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	300MG/5ML
Approval Date:	Oct 20, 2023	TE:	AB	RLD:	No

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