Carbamazepine

Product NDC: 60687-479
Requested package NDC: 60687-479-01
11-digit product format: 606870479
Labeler code: 60687
Product ID: 60687-479_5ca454de-9967-c5a6-e063-6394a90af15b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA075712
Marketing category: ANDA
Marketing start: 2020-01-03
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A075712-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	2001-07-05	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075712-001	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

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
60687-479-01	Carbamazepine	100 in 1 BOX, UNIT-DOSE	TABLET, CHEWABLE	100		6
60687-479-11	Carbamazepine	1 in 1 BLISTER PACK	TABLET, CHEWABLE	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-479-01	EA - Each	60687-479	559fa462-9262-4f65-b483-b6b504b947e8	1	2020-02-13
60687-479-11	EA - Each	60687-479	8802e12f-1513-4a72-8845-c03c7d0f1dcd	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-479	CARBAMAZEPINE TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]	5	Current NDC, Legacy NDC, 2 package rows	20241027_f8444c23-a74f-4d44-867e-26554dbb882f.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 · 4 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
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 ndc (package): 60687-479-01 ndc (product): 60687-479 ndc11 (package): 60687047901

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	f8444c23-a74f-4d44-867e-26554dbb882f	6
308973	carbamazepine 100 MG Chewable Tablet	SCD	f8444c23-a74f-4d44-867e-26554dbb882f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-479-01	60687047901	100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-479-01) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (60687-479-11)	100 blister pack	2020-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbamazepine Tablets, USP (Chewable) 8447901/0426 Rx only	American Health Packaging	2026-09-29	HUMAN PRESCRIPTION DRUG LABEL	7