CARBAMAZEPINE ER

Product NDC: 35561-357
11-digit product format: 355610357
Labeler code: 35561
Product ID: 35561-357_5094cfb0-cf09-008b-e063-6394a90a402f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbamazepine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Bostal LLC
Application: ANDA215591
Marketing category: ANDA
Marketing start: 2022-03-31
Substance: CARBAMAZEPINE
Active strength: 400 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215591-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31
A215591-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31
A215591-003	CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A215591-001	AB
A215591-002	AB
A215591-003	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 · 90 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	A215591-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215591-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215591-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215591-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215591-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215591-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215591-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215591-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215591-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215591-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215591-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215591-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215591-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215591-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215591-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215591-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215591-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215591-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215591-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215591-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215591-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215591-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215591-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215591-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215591-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215591-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215591-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215591-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215591-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215591-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215591-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215591-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215591-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215591-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215591-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215591-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215591-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215591-002	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215591-003	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215591-001	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-03-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 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	A215591-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215591-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215591-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215591-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215591-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215591-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215591-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215591-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215591-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215591-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215591-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215591-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215591-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215591-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215591-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215591-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215591-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215591-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215591-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215591-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215591-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215591-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215591-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215591-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215591-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215591-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215591-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215591-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215591-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215591-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215591-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215591-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215591-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215591-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215591-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215591-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215591-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215591-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215591-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215591-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: CARBAMAZEPINE ER
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBAMAZEPINE	400 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199378	Internal RxNorm lookup
402505	Internal RxNorm lookup
402506	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
b48741b3-0889-47b8-a26e-b12614f6e7fc	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
35561-357-12	2026-01-29	C162847	48780-1	49896155-c2f9-586f-e063-e6dba90add90	Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information
35561-357-12	2026-01-29	C162847	48780-1	49896155-c2f9-586f-e063-e6dba90add90	Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information
35561-357-12	2026-01-29	C162847	48780-1	49896155-c2f9-586f-e063-e6dba90add90	Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
35561-357-12	CARBAMAZEPINE ER	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	9
35561-357-13	CARBAMAZEPINE ER	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	9
35561-357-26	CARBAMAZEPINE ER	30 in 1 CARTON	TABLET, EXTENDED RELEASE	30	9
35561-357-99	CARBAMAZEPINE ER	33051 in 1 DRUM	TABLET, EXTENDED RELEASE	33051	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35561-357	CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [AUSTARPHARMA LLC]	4	Current NDC, Legacy NDC, 4 package rows	20241027_b48741b3-0889-47b8-a26e-b12614f6e7fc.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBAMAZEPINE ER	CARBAMAZEPINE	Bostal LLC	b48741b3-0889-47b8-a26e-b12614f6e7fc	2026-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215591 application number: ANDA215591 ndc (product): 35561-357
Carbamazepine ER	CARBAMAZEPINE ER	Chartwell RX, LLC	bf2bff52-d1ae-4b81-951c-7d39d3c5058f	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215591 application number: ANDA215591

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
199378	carBAMazepine 100 MG 12HR Extended Release Oral Tablet	PSN	b48741b3-0889-47b8-a26e-b12614f6e7fc	9
402505	carBAMazepine 200 MG 12HR Extended Release Oral Tablet	PSN	b48741b3-0889-47b8-a26e-b12614f6e7fc	9
402506	carBAMazepine 400 MG 12HR Extended Release Oral Tablet	PSN	b48741b3-0889-47b8-a26e-b12614f6e7fc	9
199378	12 HR carbamazepine 100 MG Extended Release Oral Tablet	SCD	b48741b3-0889-47b8-a26e-b12614f6e7fc	9
402505	12 HR carbamazepine 200 MG Extended Release Oral Tablet	SCD	b48741b3-0889-47b8-a26e-b12614f6e7fc	9
402506	12 HR carbamazepine 400 MG Extended Release Oral Tablet	SCD	b48741b3-0889-47b8-a26e-b12614f6e7fc	9
199378	carbamazepine 100 MG 12 HR Extended Release Oral Tablet	SY	b48741b3-0889-47b8-a26e-b12614f6e7fc	9
402505	carbamazepine 200 MG 12 HR Extended Release Oral Tablet	SY	b48741b3-0889-47b8-a26e-b12614f6e7fc	9
402506	carbamazepine 400 MG 12 HR Extended Release Oral Tablet	SY	b48741b3-0889-47b8-a26e-b12614f6e7fc	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
35561-357-12	35561035712	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-357-12)	2022-03-31	0000-00-00	No	No	Current
35561-357-13	35561035713	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-357-13)	2025-04-09		No	No	Current
35561-357-26	35561035726	30 in 1 CARTON					Historical
35561-357-99	35561035799	33051 TABLET, EXTENDED RELEASE in 1 DRUM (35561-357-99)	2025-04-27		No	No	Current