Oxcarbazepine

Product NDC: 68094-123
11-digit product format: 680940123
Labeler code: 68094
Product ID: 68094-123_43ea970d-701d-409d-b9a1-4e0c171ede4d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxcarbazepine
Dosage form: SUSPENSION
Route: ORAL
Labeler: Precision Dose, Inc.
Application: ANDA202961
Marketing category: ANDA
Marketing start: 2017-09-13
Substance: OXCARBAZEPINE
Active strength: 300 mg/5mL
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
OXCARBAZEPINE	300 mg/5mL

Field, Values table
Field	Values
Unii	VZI5B1W380
Rxcui	283536

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68094-123-59	Oxcarbazepine	5 mL in 1 CUP, UNIT-DOSE	SUSPENSION	5	3
68094-123-62	Oxcarbazepine	3 in 1 CASE	SUSPENSION	3	3
68094-123-62	Oxcarbazepine	10 in 1 TRAY	SUSPENSION	10	3

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-123-59	ML - Milliliter	68094-123	1cfaac0a-97f6-4855-b028-152df1133628	1	2017-10-13
68094-123-62	ML - Milliliter	68094-123	12ee8ac2-b6e5-4829-a248-2ebbb73a61a7	1	2017-10-13

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68094-123	OXCARBAZEPINE SUSPENSION [PRECISION DOSE, INC.]	3	Current NDC, Legacy NDC, 3 package rows	20231121_636fc847-b3d2-4255-a959-d75499fdb198.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
283536	oxacarbazepine 300 MG in 5 mL Oral Suspension	PSN	636fc847-b3d2-4255-a959-d75499fdb198	3
283536	oxcarbazepine 60 MG/ML Oral Suspension	SCD	636fc847-b3d2-4255-a959-d75499fdb198	3
283536	oxacarbazepine 300 MG per 5 ML Oral Suspension	SY	636fc847-b3d2-4255-a959-d75499fdb198	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68094-123-59	68094012359	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
68094-123-62	68094012362	3 TRAY in 1 CASE (68094-123-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-123-59)	3 tray	2017-09-13	0000-00-00	No	No	Current