Oxcarbazepine

Product NDC: 50742-613
Requested package NDC: 50742-613-01
11-digit product format: 507420613
Labeler code: 50742
Product ID: 50742-613_69d2a354-3ced-494f-bda2-f3f5c4635eaa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Oxcarbazepine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA215796
Marketing category: ANDA
Marketing start: 2025-06-01
Substance: OXCARBAZEPINE
Active strength: 600 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

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
A215796-001	OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22
A215796-002	OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22
A215796-003	OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215796-001	AB
A215796-002	AB
A215796-003	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
2026-02-19 14:30 UTC	2026-02	A215796-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215796-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215796-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215796-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215796-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215796-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215796-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215796-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215796-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215796-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2024-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215796-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2024-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215796-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL		2024-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215796-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2024-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215796-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2024-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215796-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL		2024-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215796-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL		2024-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215796-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL		2024-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215796-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL		2024-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215796-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215796-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215796-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215796-001	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215796-002	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215796-003	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	2024-11-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215796-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215796-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215796-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215796-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215796-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215796-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215796-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215796-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215796-003	AB	1	`6a471c1ec25d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215796-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215796-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215796-003	AB	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215796-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215796-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215796-003	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXCARBAZEPINE	600 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
1365653	Internal RxNorm lookup
1365842	Internal RxNorm lookup
1365844	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
70798ca9-0eda-49c0-8a7c-b775b6ae3d69	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
50742-613-01	Oxcarbazepine	100 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50742-613-01	EA - Each	50742-613	6fd207ee-fcd5-4979-8786-2dcdc1141b60	1	2025-06-13

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxcarbazepine	OXCARBAZEPINE	Ingenus Pharmaceuticals, LLC	70798ca9-0eda-49c0-8a7c-b775b6ae3d69	2025-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215796 application number: ANDA215796 ndc (package): 50742-613-01 ndc (product): 50742-613 ndc11 (package): 50742061301

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
1365653	OXcarbazepine 150 MG 24HR Extended Release Oral Tablet	PSN	70798ca9-0eda-49c0-8a7c-b775b6ae3d69	6
1365842	OXcarbazepine 300 MG 24HR Extended Release Oral Tablet	PSN	70798ca9-0eda-49c0-8a7c-b775b6ae3d69	6
1365844	OXcarbazepine 600 MG 24HR Extended Release Oral Tablet	PSN	70798ca9-0eda-49c0-8a7c-b775b6ae3d69	6
1365653	24 HR oxcarbazepine 150 MG Extended Release Oral Tablet	SCD	70798ca9-0eda-49c0-8a7c-b775b6ae3d69	6
1365842	24 HR oxcarbazepine 300 MG Extended Release Oral Tablet	SCD	70798ca9-0eda-49c0-8a7c-b775b6ae3d69	6
1365844	24 HR oxcarbazepine 600 MG Extended Release Oral Tablet	SCD	70798ca9-0eda-49c0-8a7c-b775b6ae3d69	6
1365653	oxcarbazepine 150 MG 24 HR Extended Release Oral Tablet	SY	70798ca9-0eda-49c0-8a7c-b775b6ae3d69	6
1365842	oxcarbazepine 300 MG 24 HR Extended Release Oral Tablet	SY	70798ca9-0eda-49c0-8a7c-b775b6ae3d69	6
1365844	oxcarbazepine 600 MG 24 HR Extended Release Oral Tablet	SY	70798ca9-0eda-49c0-8a7c-b775b6ae3d69	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50742-613-01	50742061301	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-613-01)	2025-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxcarbazepine	Ingenus Pharmaceuticals, LLC \| RICONPHARMA LLC	2025-04-12	HUMAN PRESCRIPTION DRUG LABEL	6