Carbamazepine

Product NDC: 55154-1396
11-digit product format: 551541396
Labeler code: 55154
Product ID: 55154-1396_31672dcc-b99d-46ab-b961-8afc29892e7e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA077272
Marketing category: ANDA
Marketing start: 2010-09-20
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077272-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07
A077272-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07
A077272-003	CARBAMAZEPINE	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07
A077272-004	CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077272-002	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 1 of 5 · 164 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	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2005-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2005-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2005-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2005-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 71 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	A077272-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077272-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077272-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077272-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077272-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077272-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077272-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077272-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077272-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077272-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077272-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077272-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077272-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077272-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077272-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077272-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077272-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077272-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077272-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077272-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077272-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077272-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077272-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077272-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077272-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077272-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077272-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077272-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077272-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077272-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077272-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077272-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077272-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077272-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077272-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077272-001	AB	1	`c0c555d07b60…`

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
232ef732-ee6d-4ac7-8e78-c619b611fbbe	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
55154-1396-0	Carbamazepine	10 in 1 BAG	TABLET	10		14
55154-1396-0	Carbamazepine	1 in 1 BLISTER PACK	TABLET	1		14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET [CARDINAL HEALTH]	5
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET [CARDINAL HEALTH]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBAMAZEPINE TABLET [CARDINAL HEALTH]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBAMAZEPINE TABLET [CARDINAL HEALTH]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET [CARDINAL HEALTH]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBAMAZEPINE TABLET [CARDINAL HEALTH]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARBAMAZEPINE TABLET [CARDINAL HEALTH]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBAMAZEPINE TABLET [CARDINAL HEALTH]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-1396	CARBAMAZEPINE TABLET [CARDINAL HEALTH 107, LLC]	12	Current NDC, Legacy NDC, 2 package rows	20250523_232ef732-ee6d-4ac7-8e78-c619b611fbbe.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	97e6e175-75e8-437b-b457-ddb1ae4e857d	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077272 application number: ANDA077272
CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	2a8c7366-ce89-47ce-8123-96f26812fca0	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077272 application number: ANDA077272
Carbamazepine	CARBAMAZEPINE	Cardinal Health 107, LLC	232ef732-ee6d-4ac7-8e78-c619b611fbbe	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077272 application number: ANDA077272 ndc (product): 55154-1396

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	232ef732-ee6d-4ac7-8e78-c619b611fbbe	14
308979	carbamazepine 200 MG Oral Tablet	SCD	232ef732-ee6d-4ac7-8e78-c619b611fbbe	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-1396-0	55154139600	10 BLISTER PACK in 1 BAG (55154-1396-0) / 1 TABLET in 1 BLISTER PACK	10 blister pack	2010-09-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbamazepine Tablets, USP, 200 mg and Carbamazepine Tablets, USP (Chewable), 100 mg	Cardinal Health 107, LLC	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	14