Carbamazepine

Product NDC: 71335-0461
11-digit product format: 713350461
Labeler code: 71335
Product ID: 71335-0461_bf0f299f-4d58-443f-a66e-e231287bbbdc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA074649
Marketing category: ANDA
Marketing start: 1996-10-03
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: 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
A074649-001	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET / ORAL	AB		1996-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074649-001	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	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`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	A074649-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074649-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074649-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074649-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074649-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074649-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074649-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074649-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074649-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074649-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074649-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074649-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074649-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074649-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074649-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074649-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074649-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074649-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074649-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074649-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074649-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074649-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074649-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074649-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074649-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074649-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074649-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074649-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074649-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074649-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074649-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074649-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074649-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074649-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074649-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074649-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074649-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074649-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074649-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074649-001	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	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
2d2c5317-4072-477b-a4e2-f6765fc71657	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
71335-0461-1	Carbamazepine	30 in 1 BOTTLE	TABLET	30	7
71335-0461-2	Carbamazepine	60 in 1 BOTTLE	TABLET	60	7
71335-0461-3	Carbamazepine	90 in 1 BOTTLE	TABLET	90	7
71335-0461-4	Carbamazepine	120 in 1 BOTTLE	TABLET	120	7
71335-0461-5	Carbamazepine	240 in 1 BOTTLE	TABLET	240	7
71335-0461-6	Carbamazepine	180 in 1 BOTTLE	TABLET	180	7
71335-0461-7	Carbamazepine	100 in 1 BOTTLE	TABLET	100	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0461	CARBAMAZEPINE TABLET [BRYANT RANCH PREPACK]	6	Current NDC, Legacy NDC, 7 package rows	20240601_2d2c5317-4072-477b-a4e2-f6765fc71657.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	40bf2923-24b1-4af1-8d20-03cf06b455a5	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649
Carbamazepine	CARBAMAZEPINE	A-S Medication Solutions	1dc2a4d3-2ebc-4c9b-a347-92acd9f231f2	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649
Carbamazepine	CARBAMAZEPINE	Golden State Medical Supply, Inc.	8a1ce79d-18ea-f30b-e053-2995a90ad1fb	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649
Carbamazepine	CARBAMAZEPINE	Sun Pharmaceutical Industries, Inc.	0526a054-3eda-49b4-b390-7d5d16e30af8	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649
Carbamazepine	CARBAMAZEPINE	PD-Rx Pharmaceuticals, Inc.	ce5aec7a-e161-46bf-8fc0-afb41689e59a	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	2d2c5317-4072-477b-a4e2-f6765fc71657	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649 ndc (product): 71335-0461
Carbamazepine	CARBAMAZEPINE	NCS HealthCare of KY, LLC dba Vangard Labs	10c9795e-358c-4f6a-b7bc-cccc179617c0	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649
Carbamazepine	CARBAMAZEPINE	Aphena Pharma Solutions - Tennessee, LLC	697f3e5a-c84b-44a6-b9f3-15e7d9bb6395	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649

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	2d2c5317-4072-477b-a4e2-f6765fc71657	7
308979	carbamazepine 200 MG Oral Tablet	SCD	2d2c5317-4072-477b-a4e2-f6765fc71657	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0461-1	71335046101	30 TABLET in 1 BOTTLE (71335-0461-1)	30 tablet	2020-07-13	0000-00-00	No	No	Current
71335-0461-2	71335046102	60 TABLET in 1 BOTTLE (71335-0461-2)	60 tablet	2024-05-29	0000-00-00	No	No	Current
71335-0461-3	71335046103	90 TABLET in 1 BOTTLE (71335-0461-3)	90 tablet	2024-05-29	0000-00-00	No	No	Current
71335-0461-4	71335046104	120 TABLET in 1 BOTTLE (71335-0461-4)	120 tablet	2024-05-29	0000-00-00	No	No	Current
71335-0461-5	71335046105	240 TABLET in 1 BOTTLE (71335-0461-5)	240 tablet	2024-05-29	0000-00-00	No	No	Current
71335-0461-6	71335046106	180 TABLET in 1 BOTTLE (71335-0461-6)	180 tablet	2024-05-29	0000-00-00	No	No	Current
71335-0461-7	71335046107	100 TABLET in 1 BOTTLE (71335-0461-7)	100 tablet	2025-09-16		No	No	Current