Carbamazepine

Product NDC: 0615-8125
11-digit product format: 006158125
Labeler code: 0615
Product ID: 0615-8125_f8c0c630-dec1-4c2b-9925-39f6a3c86909
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA075687
Marketing category: ANDA
Marketing start: 2000-10-24
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
A075687-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24
A075687-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075687-001	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`782e0a99824c…`

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	A075687-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075687-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075687-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075687-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075687-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075687-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075687-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075687-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075687-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075687-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075687-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075687-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075687-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075687-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075687-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075687-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075687-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075687-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075687-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075687-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075687-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075687-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075687-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075687-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075687-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075687-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075687-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075687-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075687-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075687-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075687-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075687-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075687-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075687-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075687-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075687-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075687-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075687-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075687-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075687-001	AB	1	`cb3db0bc1861…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308973	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
963db7cf-e9f5-496c-816e-626e89bc839e	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
0615-8125-39	Carbamazepine	30 in 1 BLISTER PACK	TABLET, CHEWABLE	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8125	CARBAMAZEPINE TABLET, CHEWABLE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	4	Current NDC, Legacy NDC, 1 package rows	20220818_963db7cf-e9f5-496c-816e-626e89bc839e.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	REMEDYREPACK INC.	9471b7fb-29d3-4009-9d0f-f20c27351db5	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	d0121be3-b904-41d3-a81a-292aa4176491	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687
Carbamazepine	CARBAMAZEPINE	Golden State Medical Supply, Inc.	536811ab-308b-4866-9185-9e4149483512	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687
Carbamazepine	CARBAMAZEPINE	Sun Pharmaceutical Industries, Inc.	0526a054-3eda-49b4-b390-7d5d16e30af8	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687
Carbamazepine	CARBAMAZEPINE	NCS HealthCare of KY, LLC dba Vangard Labs	963db7cf-e9f5-496c-816e-626e89bc839e	2022-08-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687 ndc (product): 0615-8125

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	963db7cf-e9f5-496c-816e-626e89bc839e	4
308973	carbamazepine 100 MG Chewable Tablet	SCD	963db7cf-e9f5-496c-816e-626e89bc839e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-8125-39	00615812539	30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8125-39)	2019-06-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbamazepine	NCS HealthCare of KY, LLC dba Vangard Labs	2022-08-16	HUMAN PRESCRIPTION DRUG LABEL	4