Oxcarbazepine

Product NDC: 68462-137
11-digit product format: 684620137
Labeler code: 68462
Product ID: 68462-137_80b48b96-6521-491c-831a-2356c22e39f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxcarbazepine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA077802
Marketing category: ANDA
Marketing start: 2007-10-09
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
68462-137-01	Oxcarbazepine	100 in 1 BOTTLE	TABLET, FILM COATED	100		18
68462-137-05	Oxcarbazepine	500 in 1 BOTTLE	TABLET, FILM COATED	500		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-137-01	EA - Each	68462-137	878076e5-c689-49fc-9249-942fea63726c	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 [GLENMARK PHARMACEUTICALS INC., USA]	8
OXCARBAZEPINE	ACTIVE MOIETY	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	8
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	8
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	8
OXCARBAZEPINE	ACTIVE INGREDIENT	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
OXCARBAZEPINE	ACTIVE MOIETY	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	5
OXCARBAZEPINE	ACTIVE INGREDIENT	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
OXCARBAZEPINE	ACTIVE MOIETY	VZI5B1W380	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
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXCARBAZEPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]	2
OXCARBAZEPINE	ACTIVE INGREDIENT	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
OXCARBAZEPINE	ACTIVE MOIETY	VZI5B1W380	OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OXCARBAZEPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-137	OXCARBAZEPINE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	17	Current NDC, Legacy NDC, 2 package rows	20241107_1c713b59-a628-42e6-b166-ae71c3913284.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	1c713b59-a628-42e6-b166-ae71c3913284	18
312137	OXcarbazepine 300 MG Oral Tablet	PSN	1c713b59-a628-42e6-b166-ae71c3913284	18
312138	OXcarbazepine 600 MG Oral Tablet	PSN	1c713b59-a628-42e6-b166-ae71c3913284	18
312136	oxcarbazepine 150 MG Oral Tablet	SCD	1c713b59-a628-42e6-b166-ae71c3913284	18
312137	oxcarbazepine 300 MG Oral Tablet	SCD	1c713b59-a628-42e6-b166-ae71c3913284	18
312138	oxcarbazepine 600 MG Oral Tablet	SCD	1c713b59-a628-42e6-b166-ae71c3913284	18
312136	OXcarbazepine 150 MG Oral Tablet	PSN	92919b7e-b499-4afb-8f78-1b1fff099bae	5
312137	OXcarbazepine 300 MG Oral Tablet	PSN	92919b7e-b499-4afb-8f78-1b1fff099bae	5
312138	OXcarbazepine 600 MG Oral Tablet	PSN	92919b7e-b499-4afb-8f78-1b1fff099bae	5
312136	oxcarbazepine 150 MG Oral Tablet	SCD	92919b7e-b499-4afb-8f78-1b1fff099bae	5
312137	oxcarbazepine 300 MG Oral Tablet	SCD	92919b7e-b499-4afb-8f78-1b1fff099bae	5
312138	oxcarbazepine 600 MG Oral Tablet	SCD	92919b7e-b499-4afb-8f78-1b1fff099bae	5
312136	OXcarbazepine 150 MG Oral Tablet	PSN	654d6aac-f7bf-4404-921c-5b8470c9064a	2
312136	OXcarbazepine 150 MG Oral Tablet	PSN	f98e8ce9-4d89-2740-e053-6394a90a5ddb	2
312136	OXcarbazepine 150 MG Oral Tablet	PSN	95867dcd-fd0e-4570-987b-d35939f7d7d1	2
312136	oxcarbazepine 150 MG Oral Tablet	SCD	f98e8ce9-4d89-2740-e053-6394a90a5ddb	2
312136	oxcarbazepine 150 MG Oral Tablet	SCD	654d6aac-f7bf-4404-921c-5b8470c9064a	2
312136	oxcarbazepine 150 MG Oral Tablet	SCD	95867dcd-fd0e-4570-987b-d35939f7d7d1	2
312136	OXcarbazepine 150 MG Oral Tablet	PSN	21b0cc84-b64a-75de-e063-6294a90a9dd0	1
312136	OXcarbazepine 150 MG Oral Tablet	PSN	e8a485af-a78b-49a0-9bf4-75e1cd5bb740	1
312136	OXcarbazepine 150 MG Oral Tablet	PSN	26a628b7-b33c-7f4a-e063-6394a90a0703	1
312137	OXcarbazepine 300 MG Oral Tablet	PSN	e8a485af-a78b-49a0-9bf4-75e1cd5bb740	1
312138	OXcarbazepine 600 MG Oral Tablet	PSN	e8a485af-a78b-49a0-9bf4-75e1cd5bb740	1
312136	oxcarbazepine 150 MG Oral Tablet	SCD	21b0cc84-b64a-75de-e063-6294a90a9dd0	1
312136	oxcarbazepine 150 MG Oral Tablet	SCD	e8a485af-a78b-49a0-9bf4-75e1cd5bb740	1
312136	oxcarbazepine 150 MG Oral Tablet	SCD	26a628b7-b33c-7f4a-e063-6394a90a0703	1
312137	oxcarbazepine 300 MG Oral Tablet	SCD	e8a485af-a78b-49a0-9bf4-75e1cd5bb740	1
312138	oxcarbazepine 600 MG Oral Tablet	SCD	e8a485af-a78b-49a0-9bf4-75e1cd5bb740	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-137-01	68462013701	100 TABLET, FILM COATED in 1 BOTTLE (68462-137-01)	2007-10-09	0000-00-00	No	No	Current
68462-137-05	68462013705	500 TABLET, FILM COATED in 1 BOTTLE (68462-137-05)	2007-10-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxcarbazepine	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	18
Oxcarbazepine	Coupler LLC	2024-11-11	HUMAN PRESCRIPTION DRUG LABEL	1
Oxcarbazepine - Direct_rx	Direct_rx	2024-09-09	HUMAN PRESCRIPTION DRUG LABEL	1
Oxcarbazepine	NuCare Pharmaceuticals,Inc.	2023-05-16	HUMAN PRESCRIPTION DRUG LABEL	2
Oxcarbazepine	Proficient Rx LP	2022-11-01	HUMAN PRESCRIPTION DRUG LABEL	2
Oxcarbazepine	TYA Pharmaceuticals	2013-03-31	HUMAN PRESCRIPTION DRUG LABEL	2
Oxcarbazepine	Physicians Total Care, Inc.	2011-12-14	HUMAN PRESCRIPTION DRUG LABEL	5
Oxcarbazepine Tablets	Rebel Distributors Corp	2010-10-22	HUMAN PRESCRIPTION DRUG LABEL	1

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#