Carbamazepine

Product NDC: 75834-220
Requested package NDC: 75834-220-00
11-digit product format: 758340220
Labeler code: 75834
Product ID: 75834-220_45806c19-4811-987e-e063-6394a90aa8fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET
Route: ORAL
Labeler: NIVAGEN PHARMACEUTICALS, 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: 2026-12-31
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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 ndc (package): 75834-220-00 ndc (product): 75834-220 ndc11 (package): 75834022000
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

Additional Listing Data#

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

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
e68998cb-5f91-4d7e-85a6-555efb8b0384	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	Strength	SPL version
75834-220-00	Carbamazepine	1000 in 1 BOTTLE	TABLET	1000		20
75834-220-01	Carbamazepine	100 in 1 BOTTLE	TABLET	100		20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75834-220	CARBAMAZEPINE TABLET [NIVAGEN PHARMACEUTICALS, INC.]	18	Current NDC, Legacy NDC, 2 package rows	20241225_e68998cb-5f91-4d7e-85a6-555efb8b0384.zip

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
197441	carBAMazepine 100 MG Oral Tablet	PSN	e68998cb-5f91-4d7e-85a6-555efb8b0384	20
308979	carBAMazepine 200 MG Oral Tablet	PSN	e68998cb-5f91-4d7e-85a6-555efb8b0384	20
197441	carbamazepine 100 MG Oral Tablet	SCD	e68998cb-5f91-4d7e-85a6-555efb8b0384	20
308979	carbamazepine 200 MG Oral Tablet	SCD	e68998cb-5f91-4d7e-85a6-555efb8b0384	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75834-220-00	75834022000	1000 TABLET in 1 BOTTLE (75834-220-00)	1000 tablet	2020-04-21	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	NIVAGEN PHARMACEUTICALS, INC. \| UMEDICA LABORATORIES PRIVATE LIMITED	2025-12-09	HUMAN PRESCRIPTION DRUG LABEL	20