oxcarbazepine

Product NDC: 68382-692
11-digit product format: 683820692
Labeler code: 68382
Product ID: 68382-692_f743cc83-a47d-4a48-8be5-516be5c7d7e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxcarbazepine
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA211747
Marketing category: ANDA
Marketing start: 2025-07-10
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	Approval date
A211747-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03
A211747-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET / ORAL	2023-07-03
A211747-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET / ORAL	2023-07-03

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.

Product history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2023-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2023-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2023-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2023-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2023-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2023-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2023-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2023-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2023-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2023-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2023-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2023-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2023-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2023-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2023-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2023-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2023-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2023-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2023-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2023-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2023-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2023-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2023-07-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2023-07-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211747-002	OXCARBAZEPINE	300MG	TABLET / ORAL	2023-07-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211747-003	OXCARBAZEPINE	600MG	TABLET / ORAL	2023-07-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211747-001	OXCARBAZEPINE	150MG	TABLET / ORAL	2023-07-03	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A211747-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211747-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211747-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211747-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211747-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211747-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211747-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211747-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211747-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211747-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211747-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211747-003	AB	1	`a67488948f0b…`

Additional Listing Data#

Finished product: Yes
Brand name base: oxcarbazepine
Listing expiration: 2027-12-31

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
5048dc87-2d89-434d-be51-4a97b0ce0601	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	SPL version
68382-692-01	oxcarbazepine	100 in 1 BOTTLE	TABLET	100	4
68382-692-05	oxcarbazepine	500 in 1 BOTTLE	TABLET	500	4
68382-692-10	oxcarbazepine	1000 in 1 BOTTLE	TABLET	1000	4
68382-692-30	oxcarbazepine	10 in 1 BLISTER PACK	TABLET	10	4
68382-692-30	oxcarbazepine	10 in 1 CARTON	TABLET	10	4

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
oxcarbazepine	OXCARBAZEPINE	Zydus Lifesciences Limited	e23d8a74-b47b-462a-b09c-90bdd58a032e	2026-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211747 application number: ANDA211747
oxcarbazepine	OXCARBAZEPINE	Zydus Pharmaceuticals (USA) Inc.	5048dc87-2d89-434d-be51-4a97b0ce0601	2026-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211747 application number: ANDA211747 ndc (product): 68382-692

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	5048dc87-2d89-434d-be51-4a97b0ce0601	4
312137	OXcarbazepine 300 MG Oral Tablet	PSN	5048dc87-2d89-434d-be51-4a97b0ce0601	4
312138	OXcarbazepine 600 MG Oral Tablet	PSN	5048dc87-2d89-434d-be51-4a97b0ce0601	4
312136	oxcarbazepine 150 MG Oral Tablet	SCD	5048dc87-2d89-434d-be51-4a97b0ce0601	4
312137	oxcarbazepine 300 MG Oral Tablet	SCD	5048dc87-2d89-434d-be51-4a97b0ce0601	4
312138	oxcarbazepine 600 MG Oral Tablet	SCD	5048dc87-2d89-434d-be51-4a97b0ce0601	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68382-692-01	68382069201	100 TABLET in 1 BOTTLE (68382-692-01)	100 tablet	2025-07-10	No	No	Current
68382-692-05	68382069205	500 TABLET in 1 BOTTLE (68382-692-05)	500 tablet	2025-07-10	No	No	Current
68382-692-10	68382069210	1000 TABLET in 1 BOTTLE (68382-692-10)	1000 tablet	2025-07-10	No	No	Current
68382-692-30	68382069230	10 BLISTER PACK in 1 CARTON (68382-692-30) / 10 TABLET in 1 BLISTER PACK	10 blister pack	2025-07-10	No	No	Current