Oxcarbazepine

Product NDC: 71428-007
Requested package NDC: 71428-007-25
11-digit product format: 714280007
Labeler code: 71428
Product ID: 71428-007_ee9d7ea0-c2ea-52cb-e053-2995a90a5ff7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxcarbazepine
Dosage form: SUSPENSION
Route: ORAL
Labeler: Glasshouse Pharmaceuticals Limited Canada
Application: ANDA212428
Marketing category: ANDA
Marketing start: 2021-09-21
Marketing end: 0000-00-00
Substance: OXCARBAZEPINE
Active strength: 300 mg/5mL
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71428-007	71428-007-25	D	Discontinued by firm		2026-08-11

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 · 12 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
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
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…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212428-001	OXCARBAZEPINE	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB		2021-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212428-001	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	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212428-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2021-06-21	`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	A212428-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212428-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212428-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212428-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212428-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212428-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212428-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212428-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212428-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212428-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212428-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212428-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212428-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212428-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212428-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212428-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212428-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212428-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212428-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212428-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212428-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212428-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212428-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212428-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212428-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212428-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212428-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212428-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212428-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212428-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212428-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212428-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212428-001	AB	1	`a50c72e98297…`

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	Chartwell RX, LLC	c2affa00-1d57-4d85-8db3-745191b4714d	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212428 application number: ANDA212428
Oxcarbazepine	OXCARBAZEPINE	Chartwell Governmental & Specialty RX, LLC.	e74bb389-8426-4ffc-a14b-a5990de6d0d4	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212428 application number: ANDA212428

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71428-007-25	71428000725	1 BOTTLE in 1 CARTON (71428-007-25) > 250 mL in 1 BOTTLE	1 bottle	2021-09-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxcarbazepine	Glasshouse Pharmaceuticals Limited Canada	2022-11-29	HUMAN PRESCRIPTION DRUG LABEL	3