Carbamazepine

Product NDC: 60290-034
11-digit product format: 602900034
Labeler code: 60290
Product ID: 60290-034_58d8ef92-49c0-13fb-e063-6394a90a94d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET
Route: ORAL
Labeler: Umedica Laboratories USA Inc.
Application: ANDA207798
Marketing category: ANDA
Marketing start: 2020-04-21
Substance: CARBAMAZEPINE
Active strength: 100 mg/1
Pharmacologic classes: Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207798-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET / ORAL	BX		2020-04-15
A207798-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET / ORAL	BX		2020-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207798-001	BX
A207798-002	BX

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 · 78 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
2026-09-14 22:38:34	2026-08	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	BX	2020-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	BX	2020-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A207798-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207798-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207798-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207798-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207798-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207798-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207798-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207798-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207798-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207798-002	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207798-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207798-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207798-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207798-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207798-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207798-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207798-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207798-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207798-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207798-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207798-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207798-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207798-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207798-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207798-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207798-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207798-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207798-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207798-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207798-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207798-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A207798-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207798-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A207798-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207798-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207798-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207798-001	BX	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207798-002	BX	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBAMAZEPINE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
33CM23913M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197441	Internal RxNorm lookup
308979	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
f3465f71-8931-43b6-baea-eac7046a4400	Available on FDA.report

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	Umedica Laboratories USA Inc.	f3465f71-8931-43b6-baea-eac7046a4400	2026-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798 ndc (product): 60290-034
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	9f3d91cd-a959-4e07-a51b-8a4e9ba9ece2	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798
Carbamazepine	CARBAMAZEPINE	Coupler LLC	544e3b55-c8a3-a480-e063-6394a90abbb5	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	62d38b93-7dd0-48e7-bd59-a434d52520f6	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798
Carbamazepine	CARBAMAZEPINE	Preferred Pharmaceuticals Inc.	867a5f4d-8ae6-4339-bbb4-0bf62fb082e5	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798
Carbamazepine	CARBAMAZEPINE	NIVAGEN PHARMACEUTICALS, INC.	e68998cb-5f91-4d7e-85a6-555efb8b0384	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798
Carbamazepine	CARBAMAZEPINE	A-S Medication Solutions	047bc284-060a-4db9-bf37-75d10f95a0a6	2025-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798
CARBAMAZEPINE	CARBAMAZEPINE	direct rx	b56dd9c8-1bca-21e3-e053-2995a90a3e6e	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207798 application number: ANDA207798

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33CM23913M	CARBAMAZEPINE	298-46-4	CARBAMAZEPINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60290-034-02	60290003402	100 TABLET in 1 BOTTLE (60290-034-02)	100 tablet	2020-04-21	No	No	Current
60290-034-03	60290003403	1000 TABLET in 1 BOTTLE (60290-034-03)	1000 tablet	2020-04-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbamazepine Tablets USP, 100 mg and 200 mg Rx only Prescribing Information	Umedica Laboratories USA Inc. \| UMEDICA LABORATORIES PRIVATE LIMITED	2026-08-12	HUMAN PRESCRIPTION DRUG LABEL	4