CARBAMAZEPINE

Product NDC: 13668-271
11-digit product format: 136680271
Labeler code: 13668
Product ID: 13668-271_2b305f64-7c1a-4cf6-a4ad-57326eb4c874
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARBAMAZEPINE
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA075712
Marketing category: ANDA
Marketing start: 2009-08-26
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 42.

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
A075712-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2001-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075712-001	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 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075712-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075712-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075712-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075712-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075712-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075712-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075712-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075712-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075712-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075712-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075712-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075712-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075712-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075712-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075712-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075712-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075712-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075712-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075712-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075712-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075712-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075712-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075712-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075712-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075712-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075712-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075712-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075712-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075712-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075712-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075712-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075712-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075712-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075712-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075712-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075712-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075712-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075712-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075712-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075712-001	AB	1	`e64feba35796…`

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
308973	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
97e6e175-75e8-437b-b457-ddb1ae4e857d	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
13668-271-01	CARBAMAZEPINE	100 in 1 BOTTLE	TABLET, CHEWABLE	100	22
13668-271-05	CARBAMAZEPINE	500 in 1 BOTTLE	TABLET, CHEWABLE	500	22
13668-271-10	CARBAMAZEPINE	1000 in 1 BOTTLE	TABLET, CHEWABLE	1000	22
13668-271-49	CARBAMAZEPINE	750 in 1 BOTTLE	TABLET, CHEWABLE	750	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-271-01	EA - Each	13668-271	fa728c2c-69b5-4397-bf27-7254b26adda1	1	2012-07-24
13668-271-05	EA - Each	13668-271	2dc90b7a-0983-4712-9867-ba558c6ca052	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	12
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	12
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	12
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	12
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	12
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	12
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]	12
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]	9
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]	9
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]	9
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]	9
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]	9
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]	9
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBAMAZEPINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	6
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CARBAMAZEPINE TABLET, CHEWABLE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-271	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [TORRENT PHARMACEUTICALS LIMITED]	21	Current NDC, Legacy NDC, 4 package rows	20250223_97e6e175-75e8-437b-b457-ddb1ae4e857d.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 · 5 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	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075712 application number: ANDA075712 ndc (product): 13668-271
CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	2a8c7366-ce89-47ce-8123-96f26812fca0	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075712 application number: ANDA075712
CARBAMAZEPINE	CARBAMAZEPINE	Coupler LLC	5461e739-0f18-b012-e063-6394a90a6b14	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075712 application number: ANDA075712
CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	c72a0668-7cd7-46a8-86d1-d3c17c4b900f	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075712 application number: ANDA075712
Carbamazepine	CARBAMAZEPINE	American Health Packaging	f8444c23-a74f-4d44-867e-26554dbb882f	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075712 application number: ANDA075712

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
308973	carBAMazepine 100 MG Chewable Tablet	PSN	c72a0668-7cd7-46a8-86d1-d3c17c4b900f	101
308973	carbamazepine 100 MG Chewable Tablet	SCD	c72a0668-7cd7-46a8-86d1-d3c17c4b900f	101
308973	carBAMazepine 100 MG Chewable Tablet	PSN	2a8c7366-ce89-47ce-8123-96f26812fca0	27
308979	carBAMazepine 200 MG Oral Tablet	PSN	2a8c7366-ce89-47ce-8123-96f26812fca0	27
308973	carbamazepine 100 MG Chewable Tablet	SCD	2a8c7366-ce89-47ce-8123-96f26812fca0	27
308979	carbamazepine 200 MG Oral Tablet	SCD	2a8c7366-ce89-47ce-8123-96f26812fca0	27
308973	carBAMazepine 100 MG Chewable Tablet	PSN	97e6e175-75e8-437b-b457-ddb1ae4e857d	22
308979	carBAMazepine 200 MG Oral Tablet	PSN	97e6e175-75e8-437b-b457-ddb1ae4e857d	22
308973	carbamazepine 100 MG Chewable Tablet	SCD	97e6e175-75e8-437b-b457-ddb1ae4e857d	22
308979	carbamazepine 200 MG Oral Tablet	SCD	97e6e175-75e8-437b-b457-ddb1ae4e857d	22
308973	carBAMazepine 100 MG Chewable Tablet	PSN	f8444c23-a74f-4d44-867e-26554dbb882f	6
308973	carbamazepine 100 MG Chewable Tablet	SCD	f8444c23-a74f-4d44-867e-26554dbb882f	6
308973	carBAMazepine 100 MG Chewable Tablet	PSN	1d6698da-dacd-44e3-8af1-976bc7427de1	2
308973	carbamazepine 100 MG Chewable Tablet	SCD	1d6698da-dacd-44e3-8af1-976bc7427de1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-271-01	13668027101	100 TABLET, CHEWABLE in 1 BOTTLE (13668-271-01)	2009-08-26	0000-00-00	No	No	Current
13668-271-05	13668027105	500 TABLET, CHEWABLE in 1 BOTTLE (13668-271-05)	2009-08-26	0000-00-00	No	No	Current
13668-271-10	13668027110	1000 TABLET, CHEWABLE in 1 BOTTLE (13668-271-10)	2009-08-26	0000-00-00	No	No	Current
13668-271-49	13668027149	750 TABLET, CHEWABLE in 1 BOTTLE (13668-271-49)	2009-08-26	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	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	25
Carbamazepine Tablets, USP, 200 mg and Carbamazepine Tablets, USP (Chewable), 100 mg	Major Pharmaceuticals	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL	28
Carbamazepine Tablets, USP, 200 mg and Carbamazepine Tablets, USP (Chewable), 100 mg	Coupler LLC \| Torrent Pharma, Inc.	2026-06-16	HUMAN PRESCRIPTION DRUG LABEL	1
Carbamazepine Tablets, USP, 200 mg and Carbamazepine Tablets, USP (Chewable), 100 mg	Bryant Ranch Prepack	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	101
Carbamazepine Tablets, USP (Chewable) 8447901/1125 Rx only	American Health Packaging	2025-12-05	HUMAN PRESCRIPTION DRUG LABEL	6
Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mg	REMEDYREPACK INC.	2024-12-04	HUMAN PRESCRIPTION DRUG LABEL	3
Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mg	Bryant Ranch Prepack	2022-03-09	HUMAN PRESCRIPTION DRUG LABEL	1003
Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mg	Clinical Solutions Wholesale \| Clincal Solutions Wholesale	2020-09-04	HUMAN PRESCRIPTION DRUG LABEL	8
Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mg	State of Florida DOH Central Pharmacy	2014-03-07	HUMAN PRESCRIPTION DRUG LABEL	2
Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mg	NCS HealthCare of KY, Inc dba Vangard Labs	2013-03-15	HUMAN PRESCRIPTION DRUG LABEL	6