Oxcarbazepine

Product NDC: 63304-653
11-digit product format: 633040653
Labeler code: 63304
Product ID: 63304-653_5989f59b-7495-45ed-a245-1e404264175e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: oxcarbazepine
Dosage form: SUSPENSION
Route: ORAL
Labeler: Ranbaxy Pharmaceuticals Inc.
Application: ANDA078734
Marketing category: ANDA
Marketing start: 2009-12-14
Marketing end: 0000-00-00
Substance: OXCARBAZEPINE
Active strength: 60 mg/mL
Pharmacologic classes: Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63304-653		D	Discontinued by firm		2026-10-05
excluded package	package	63304-653	63304-653-25	D	Discontinued by firm		2026-10-05

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-653-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-653-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-653-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-653-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-653-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-653-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-653-25	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-653-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-653-25	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-653-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-653-25	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-653-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63304-653-25	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63304-653-25	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63304-653-25	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	63304-653-25	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	63304-653-25	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	63304-653-25	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63304-653-25	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63304-653-25	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63304-653-25	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078734-001	OXCARBAZEPINE	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB		2009-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078734-001	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.

Product history page 2 of 2 · 43 observed 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
2022-09-29 23:25 UTC	2022-09	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078734-001	OXCARBAZEPINE	300MG/5ML	SUSPENSION / ORAL	AB	2009-06-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078734-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078734-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078734-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078734-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078734-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078734-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078734-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078734-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078734-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078734-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078734-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078734-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078734-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078734-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078734-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078734-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078734-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078734-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078734-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078734-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078734-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078734-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078734-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078734-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078734-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078734-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078734-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078734-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078734-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078734-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078734-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078734-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078734-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078734-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078734-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078734-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078734-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078734-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078734-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078734-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63304-653-25	2020-01-31	C162847	48780-1	9d75b9d0-5e7e-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use oxcarbazepine oral suspension, USP safely and effectively. See full prescribing information for oxcarbazepine oral suspension, USP. Oxcarbazepine oral suspension, USP for oral administration Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63304-653-25	Oxcarbazepine	250 mL in 1 BOTTLE	SUSPENSION	250		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-653-25	ML - Milliliter	63304-653	67010cc1-d1c5-4a7f-8f8a-27de16d84ea1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXCARBAZEPINE	ACTIVE INGREDIENT	VZI5B1W380	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
OXCARBAZEPINE	ACTIVE MOIETY	VZI5B1W380	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
PEG-8 STEARATE	INACTIVE INGREDIENT	2P9L47VI5E	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
SORBITOL	INACTIVE INGREDIENT	506T60A25R	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-653	OXCARBAZEPINE SUSPENSION [RANBAXY PHARMACEUTICALS INC.]	8	Legacy NDC, 1 package rows	20150217_ca6bfbbb-fcca-4c15-a160-ee5791ed2f6e.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
283536	oxacarbazepine 300 MG in 5 mL Oral Suspension	PSN	ca6bfbbb-fcca-4c15-a160-ee5791ed2f6e	8
283536	oxcarbazepine 60 MG/ML Oral Suspension	SCD	ca6bfbbb-fcca-4c15-a160-ee5791ed2f6e	8
283536	oxacarbazepine 300 MG per 5 ML Oral Suspension	SY	ca6bfbbb-fcca-4c15-a160-ee5791ed2f6e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
63304-653-25	63304065325	250 mL in 1 BOTTLE	250 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Oxcarbazepine	Ranbaxy Pharmaceuticals Inc. \| DPT Laboratories Ltd	2015-02-17	HUMAN PRESCRIPTION DRUG LABEL	8