Oxcarbazepine

Product NDC: 68462-138
11-digit product format: 684620138
Labeler code: 68462
Product ID: 68462-138_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: 300 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077802-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09
A077802-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09
A077802-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077802-001	AB
A077802-002	AB
A077802-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A077802-001	OXCARBAZEPINE	150MG	TABLET / ORAL	AB	2007-10-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077802-002	OXCARBAZEPINE	300MG	TABLET / ORAL	AB	2007-10-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077802-003	OXCARBAZEPINE	600MG	TABLET / ORAL	AB	2007-10-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A077802-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077802-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A077802-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	51008af2-39ac-546c-e063-6294a90a758f	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Coupler LLC	50873ef7-3deb-7386-e063-6394a90a9c19	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	a90cd1f1-5258-4b0e-92fd-c4cebe47772b	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	a2032bcc-2da5-45e5-aa3f-ddbf50909df8	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Glenmark Pharmaceuticals Inc., USA	1c713b59-a628-42e6-b166-ae71c3913284	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802 ndc (product): 68462-138
Oxcarbazepine	OXCARBAZEPINE	Direct_rx	21b0cc84-b64a-75de-e063-6294a90a9dd0	2024-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802
Oxcarbazepine	OXCARBAZEPINE	Proficient Rx LP	95867dcd-fd0e-4570-987b-d35939f7d7d1	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077802 application number: ANDA077802

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXCARBAZEPINE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VZI5B1W380	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312136	Internal RxNorm lookup
312137	Internal RxNorm lookup
312138	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1c713b59-a628-42e6-b166-ae71c3913284	Available on FDA.report

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
68462-138-01	Oxcarbazepine	100 in 1 BOTTLE	TABLET, FILM COATED	100		18
68462-138-05	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
68462-138-01	EA - Each	68462-138	6893ebe3-a4b6-4b39-b51c-7d389fa69e92	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 [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
68462-138	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
312137	OXcarbazepine 300 MG Oral Tablet	PSN	a2032bcc-2da5-45e5-aa3f-ddbf50909df8	8
312137	oxcarbazepine 300 MG Oral Tablet	SCD	a2032bcc-2da5-45e5-aa3f-ddbf50909df8	8
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	e8a485af-a78b-49a0-9bf4-75e1cd5bb740	1
312137	OXcarbazepine 300 MG Oral Tablet	PSN	51008af2-39ac-546c-e063-6294a90a758f	1
312137	OXcarbazepine 300 MG Oral Tablet	PSN	33af9350-95f3-384e-e054-00144ff88e88	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
261360	Trileptal 300 MG Oral Tablet	PSN	33af9350-95f3-384e-e054-00144ff88e88	1
261360	oxcarbazepine 300 MG Oral Tablet [Trileptal]	SBD	33af9350-95f3-384e-e054-00144ff88e88	1
312136	oxcarbazepine 150 MG Oral Tablet	SCD	e8a485af-a78b-49a0-9bf4-75e1cd5bb740	1
312137	oxcarbazepine 300 MG Oral Tablet	SCD	51008af2-39ac-546c-e063-6294a90a758f	1
312137	oxcarbazepine 300 MG Oral Tablet	SCD	e8a485af-a78b-49a0-9bf4-75e1cd5bb740	1
312137	oxcarbazepine 300 MG Oral Tablet	SCD	33af9350-95f3-384e-e054-00144ff88e88	1
312138	oxcarbazepine 600 MG Oral Tablet	SCD	e8a485af-a78b-49a0-9bf4-75e1cd5bb740	1
261360	Trileptal 300 MG Oral Tablet	SY	33af9350-95f3-384e-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-138-01	68462013801	100 TABLET, FILM COATED in 1 BOTTLE (68462-138-01)	2007-10-09	0000-00-00	No	No	Current
68462-138-05	68462013805	500 TABLET, FILM COATED in 1 BOTTLE (68462-138-05)	2007-10-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxcarbazepine	Coupler LLC	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	1
Oxcarbazepine	REMEDYREPACK INC.	2026-02-17	HUMAN PRESCRIPTION DRUG LABEL	8
Oxcarbazepine	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	18
Oxcarbazepine	A-S Medication Solutions	2018-12-17	HUMAN PRESCRIPTION DRUG LABEL	3
OXCARBAZEPINE	DIRECT RX	2016-05-25	HUMAN PRESCRIPTION DRUG LABEL	1
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