Carbamazepine

Product NDC: 51672-4150
Requested package NDC: 51672-4150-1
11-digit product format: 516724150
Labeler code: 51672
Product ID: 51672-4150_2708f550-3bdc-4550-99ed-f98db2a24475
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: ANDA201106
Marketing category: ANDA
Marketing start: 2013-06-21
Marketing end: 0000-00-00
Substance: CARBAMAZEPINE
Active strength: 200 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51672-4150	51672-4150-1	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51672-4150	51672-4150-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51672-4150	51672-4150-1	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

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	Approval date
A201106-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-06-21
A201106-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-06-21
A201106-003	CARBAMAZEPINE	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	2013-06-21

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 4 · 129 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	A201106-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201106-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201106-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201106-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201106-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201106-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201106-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201106-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201106-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201106-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201106-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201106-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201106-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201106-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201106-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201106-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201106-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201106-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201106-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201106-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201106-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201106-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201106-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201106-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201106-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201106-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201106-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201106-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201106-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201106-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201106-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201106-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201106-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201106-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201106-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201106-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201106-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201106-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201106-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201106-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-06-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A201106-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201106-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201106-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201106-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201106-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201106-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201106-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201106-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201106-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201106-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201106-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201106-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201106-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201106-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201106-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201106-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201106-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201106-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201106-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201106-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201106-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201106-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201106-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201106-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201106-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201106-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201106-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201106-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201106-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201106-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201106-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201106-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201106-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201106-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201106-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201106-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201106-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201106-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201106-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201106-001	AB	1	`5d02ea3f76ae…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4150-1	EA - Each	51672-4150	c479a8cd-37ad-47a9-8ab0-94a66d047dee	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Carbamazepine	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]	3
Carbamazepine	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]	3
ammonio methacrylate copolymer type a	INACTIVE INGREDIENT	8GQS4E66YY	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]	3
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]	3
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]	3
gelatin	INACTIVE INGREDIENT	2G86QN327L	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]	3
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]	3
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]	3
sodium starch glycolate type a potato	INACTIVE INGREDIENT	5856J3G2A2	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]	3
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-4150	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [TARO PHARMACEUTICALS U.S.A., INC.]	5	Legacy NDC	20241211_f4b93cb8-a980-4bae-a743-d5389fdf6899.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33CM23913M	CARBAMAZEPINE	298-46-4	CARBAMAZEPINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-4150-1	51672415001	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51672-4150-1)	2013-06-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbamazepine Extended-Release Capsules, 100 mg, 200 mg and 300 mg	Taro Pharmaceuticals U.S.A., Inc. \| Taro Pharmaceutical Industries, Ltd.	2024-12-10	HUMAN PRESCRIPTION DRUG LABEL	5