OXCARBAZEPINE

Product NDC: 51991-292
11-digit product format: 519910292
Labeler code: 51991
Product ID: 51991-292_7b71db65-df59-4739-9e8f-77aea32f80b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OXCARBAZEPINE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Breckenridge Pharmaceutical, Inc.
Application: ANDA078069
Marketing category: ANDA
Marketing start: 2008-01-11
Substance: OXCARBAZEPINE
Active strength: 150 mg/1
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#

Finished product: Yes
Brand name base: OXCARBAZEPINE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXCARBAZEPINE	150 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	VZI5B1W380
Rxcui	312136, 312137, 312138

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51991-292-01	OXCARBAZEPINE	100 in 1 BOTTLE	TABLET, FILM COATED	100		22
51991-292-05	OXCARBAZEPINE	500 in 1 BOTTLE	TABLET, FILM COATED	500		22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51991-292-01	EA - Each	51991-292	3afb3458-c05f-4098-946f-2b396118f2f5	1	2012-07-24
51991-292-05	EA - Each	51991-292	c0aea7b9-9120-4224-bcfe-8089ea88a66a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXCARBAZEPINE	ACTIVE INGREDIENT	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
OXCARBAZEPINE	ACTIVE MOIETY	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXCARBAZEPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]	1000
OXCARBAZEPINE	ACTIVE INGREDIENT	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
OXCARBAZEPINE	ACTIVE MOIETY	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	12
OXCARBAZEPINE	ACTIVE INGREDIENT	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
OXCARBAZEPINE	ACTIVE MOIETY	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXCARBAZEPINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY]	3
OXCARBAZEPINE	ACTIVE INGREDIENT	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
OXCARBAZEPINE	ACTIVE MOIETY	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51991-292	OXCARBAZEPINE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	22	Current NDC, Legacy NDC, 2 package rows	20240327_682a1210-b26e-426e-8ffe-d25d91bdd608.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312136	OXcarbazepine 150 MG Oral Tablet	PSN	78f196d4-110e-45b1-813a-725f52c1a4eb	1007
312136	oxcarbazepine 150 MG Oral Tablet	SCD	78f196d4-110e-45b1-813a-725f52c1a4eb	1007
312136	OXcarbazepine 150 MG Oral Tablet	PSN	682a1210-b26e-426e-8ffe-d25d91bdd608	22
312137	OXcarbazepine 300 MG Oral Tablet	PSN	682a1210-b26e-426e-8ffe-d25d91bdd608	22
312138	OXcarbazepine 600 MG Oral Tablet	PSN	682a1210-b26e-426e-8ffe-d25d91bdd608	22
312136	oxcarbazepine 150 MG Oral Tablet	SCD	682a1210-b26e-426e-8ffe-d25d91bdd608	22
312137	oxcarbazepine 300 MG Oral Tablet	SCD	682a1210-b26e-426e-8ffe-d25d91bdd608	22
312138	oxcarbazepine 600 MG Oral Tablet	SCD	682a1210-b26e-426e-8ffe-d25d91bdd608	22
312136	OXcarbazepine 150 MG Oral Tablet	PSN	b9db5c45-8b51-449b-b4af-1a235c08f189	18
312137	OXcarbazepine 300 MG Oral Tablet	PSN	b9db5c45-8b51-449b-b4af-1a235c08f189	18
312138	OXcarbazepine 600 MG Oral Tablet	PSN	b9db5c45-8b51-449b-b4af-1a235c08f189	18
312136	oxcarbazepine 150 MG Oral Tablet	SCD	b9db5c45-8b51-449b-b4af-1a235c08f189	18
312137	oxcarbazepine 300 MG Oral Tablet	SCD	b9db5c45-8b51-449b-b4af-1a235c08f189	18
312138	oxcarbazepine 600 MG Oral Tablet	SCD	b9db5c45-8b51-449b-b4af-1a235c08f189	18
312136	OXcarbazepine 150 MG Oral Tablet	PSN	b571ee0f-3c2a-4c55-9c2b-e00014e2ec7a	15
312136	oxcarbazepine 150 MG Oral Tablet	SCD	b571ee0f-3c2a-4c55-9c2b-e00014e2ec7a	15
312136	OXcarbazepine 150 MG Oral Tablet	PSN	b1d54def-057d-4608-bc8f-1d967ac3ec91	4
312137	OXcarbazepine 300 MG Oral Tablet	PSN	b1d54def-057d-4608-bc8f-1d967ac3ec91	4
312138	OXcarbazepine 600 MG Oral Tablet	PSN	b1d54def-057d-4608-bc8f-1d967ac3ec91	4
312136	oxcarbazepine 150 MG Oral Tablet	SCD	b1d54def-057d-4608-bc8f-1d967ac3ec91	4
312137	oxcarbazepine 300 MG Oral Tablet	SCD	b1d54def-057d-4608-bc8f-1d967ac3ec91	4
312138	oxcarbazepine 600 MG Oral Tablet	SCD	b1d54def-057d-4608-bc8f-1d967ac3ec91	4
312136	OXcarbazepine 150 MG Oral Tablet	PSN	6b4f9f7b-b48a-4dfd-bff5-9405cb38eff2	2
312136	oxcarbazepine 150 MG Oral Tablet	SCD	6b4f9f7b-b48a-4dfd-bff5-9405cb38eff2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51991-292-01	51991029201	100 TABLET, FILM COATED in 1 BOTTLE (51991-292-01)	2008-01-11	0000-00-00	No	No	Current
51991-292-05	51991029205	500 TABLET, FILM COATED in 1 BOTTLE (51991-292-05)	2008-01-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OXCARBAZEPINE	REMEDYREPACK INC.	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	15
OXCARBAZEPINE	Golden State Medical Supply, Inc.	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL	18
OXCARBAZEPINE	Major Pharmaceuticals	2025-11-13	HUMAN PRESCRIPTION DRUG LABEL	4
OXCARBAZEPINE	Bryant Ranch Prepack	2024-04-04	HUMAN PRESCRIPTION DRUG LABEL	1007
OXCARBAZEPINE	Breckenridge Pharmaceutical, Inc. \| LGM Pharma Solutions, LLC \| Towa Pharmaceutical Europe, S.L.	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	22
OXCARBAZEPINE	TYA Pharmaceuticals	2013-05-01	HUMAN PRESCRIPTION DRUG LABEL	2

OXCARBAZEPINE

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#