OXCARBAZEPINE

Product NDC: 50090-5003
11-digit product format: 500905003
Labeler code: 50090
Product ID: 50090-5003_c310485a-a7ff-421d-8f05-557cdd3de5da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXCARBAZEPINE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA078069
Marketing category: ANDA
Marketing start: 2008-01-11
Marketing end: 0000-00-00
Substance: OXCARBAZEPINE
Active strength: 300 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ca2a6da1-5711-44d0-9e79-c84d4265f98b	Product name	3	20250724
536d5b6b-66f1-478b-2670-88fd15947e3b	Product name	7	20250218
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5003-0	2023-01-30	C162847	48780-1	f386c64a-04da-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use OXCARBAZEPINE TABLETS safely and effectively. See full prescribing information for OXCARBAZEPINE TABLETS. Oxcarbazepine film-coated tablets, for oral use Initial U.S. Approval: 2000

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5003-0	OXCARBAZEPINE	33 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	33		2
50090-5003-0	OXCARBAZEPINE	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5003	OXCARBAZEPINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	2	Legacy NDC, 2 package rows	20210303_13153993-6f10-4feb-b80a-bc3144f73881.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VZI5B1W380	OXCARBAZEPINE	28721-07-5	OXCARBAZEPINE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312137	OXcarbazepine 300 MG Oral Tablet	PSN	13153993-6f10-4feb-b80a-bc3144f73881	2
312137	oxcarbazepine 300 MG Oral Tablet	SCD	13153993-6f10-4feb-b80a-bc3144f73881	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5003-0	50090500300	33 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-5003-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK	33 blister pack	2020-04-10	0000-00-00	No	No	Current