Carbamazepine

Product NDC: 68788-7825
11-digit product format: 687887825
Labeler code: 68788
Product ID: 68788-7825_f38ba895-3121-4583-98f8-6954ecd2c8e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA207798
Marketing category: ANDA
Marketing start: 2021-01-08
Substance: CARBAMAZEPINE
Active strength: 200 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 1.

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 · 74 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
2026-02-19 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…`
2021-12-28 21:50 UTC	2021-12	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207798-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2020-04-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207798-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2020-04-15	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207798-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207798-002	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207798-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207798-002	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207798-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207798-002	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207798-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207798-002	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207798-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207798-002	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207798-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207798-002	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207798-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207798-002	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207798-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207798-002	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207798-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207798-002	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207798-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207798-002	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207798-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207798-002	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207798-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207798-002	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207798-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207798-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207798-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207798-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207798-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207798-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207798-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207798-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207798-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207798-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207798-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207798-002	AB	1	`bb7c543d1eb4…`
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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBAMAZEPINE	200 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
867a5f4d-8ae6-4339-bbb4-0bf62fb082e5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
26452c40-1589-928d-2fae-b84a1d1cf183	Product name	9	20251105
2275add5-bc9e-431c-8e27-74c11f3127d5	Product name	1	20200728
7c710123-0208-426b-be07-b37720f2767d	Product name	1	20161206
8448f819-8511-2a70-1d0e-32e16eac918d	Product name	1	20140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-7825-1	Carbamazepine	100 in 1 BOTTLE	TABLET	100	6
68788-7825-3	Carbamazepine	30 in 1 BOTTLE	TABLET	30	6
68788-7825-6	Carbamazepine	60 in 1 BOTTLE	TABLET	60	6
68788-7825-9	Carbamazepine	90 in 1 BOTTLE	TABLET	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7825-1	EA - Each	68788-7825	068414f5-fb2b-459e-b056-1b0f06ab14bf	1	2021-02-05
68788-7825-3	EA - Each	68788-7825	dfd9ba4d-b89d-4db3-bb60-4402312f5364	1	2021-02-05
68788-7825-6	EA - Each	68788-7825	fef0ae5e-2b5c-4d0a-910c-a6e59900727d	1	2021-02-05
68788-7825-9	EA - Each	68788-7825	ea217b1b-1a4a-4427-9413-c52519d45bde	1	2021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7825	CARBAMAZEPINE TABLET [PREFERRED PHARMACEUTICALS INC.]	5	Current NDC, Legacy NDC, 4 package rows	20250215_867a5f4d-8ae6-4339-bbb4-0bf62fb082e5.zip

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	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	Umedica Laboratories USA Inc.	f3465f71-8931-43b6-baea-eac7046a4400	2026-06-04	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 ndc (product): 68788-7825
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308979	carBAMazepine 200 MG Oral Tablet	PSN	867a5f4d-8ae6-4339-bbb4-0bf62fb082e5	6
308979	carbamazepine 200 MG Oral Tablet	SCD	867a5f4d-8ae6-4339-bbb4-0bf62fb082e5	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7825-1	68788782501	100 TABLET in 1 BOTTLE (68788-7825-1)	100 tablet	2021-01-08	0000-00-00	No	No	Current
68788-7825-3	68788782503	30 TABLET in 1 BOTTLE (68788-7825-3)	30 tablet	2021-01-08	0000-00-00	No	No	Current
68788-7825-6	68788782506	60 TABLET in 1 BOTTLE (68788-7825-6)	60 tablet	2021-01-08	0000-00-00	No	No	Current
68788-7825-9	68788782509	90 TABLET in 1 BOTTLE (68788-7825-9)	90 tablet	2021-01-08	0000-00-00	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	Preferred Pharmaceuticals Inc.	2026-03-20	HUMAN PRESCRIPTION DRUG LABEL	6