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 1.

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 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075712-001	AB	1	`cb3db0bc1861…`

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 · 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	2026-07-23	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

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

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	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	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	23
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