Carbamazepine

Product NDC: 29033-019
11-digit product format: 290330019
Labeler code: 29033
Product ID: 29033-019_9fcd6487-e123-44ca-a48f-3aa2e5858979
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbamazepine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Nostrum Laboratories, Inc.
Application: ANDA076697
Marketing category: ANDA
Marketing start: 2020-02-17
Marketing end: 0000-00-00
Substance: CARBAMAZEPINE
Active strength: 100 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	29033-019		I	Inactivated by FDA	2026-10-05
excluded product	product	29033-019		D	Discontinued by firm	2026-10-05
excluded package	package	29033-019	29033-019-12	I	Inactivated by FDA	2026-10-05
excluded package	package	29033-019	29033-019-12	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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	29033-019-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	29033-019-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	29033-019-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	29033-019-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	29033-019-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	29033-019-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	29033-019-12	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	29033-019-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	29033-019-12	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	29033-019-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	29033-019-12	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	29033-019-12	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	TE codes	Approval date
A076697-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20
A076697-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20
A076697-003	CARBAMAZEPINE	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076697-001	AB
A076697-002	AB
A076697-003	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 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	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076697-002	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076697-003	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076697-001	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 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	A076697-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076697-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076697-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076697-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076697-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076697-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076697-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076697-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076697-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076697-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076697-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076697-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076697-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076697-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076697-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076697-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076697-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076697-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076697-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076697-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076697-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076697-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076697-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076697-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076697-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076697-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076697-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076697-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076697-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076697-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076697-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076697-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076697-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076697-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076697-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076697-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076697-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076697-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076697-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076697-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

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
29033-019-12	2026-01-29	C162847	48780-1	49896155-ba75-586f-e063-e6dba90add90	Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
29033-019-12	Carbamazepine	120 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	120		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29033-019-12	EA - Each	29033-019	73ff2f62-113e-4009-aa1b-c26ff4def38c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
ETHYLCELLULOSE (20 MPA.S)	INACTIVE INGREDIENT	BJG0S321QY	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29033-019	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	10	Legacy NDC, 1 package rows	20240216_fbca2152-0022-47a5-a1ea-58950b45bcbf.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	ANI Pharmaceuticals, Inc.	c1876184-0323-4b06-b459-603b40c0c002	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076697 application number: ANDA076697
Carbamazepine	CARBAMAZEPINE	Coupler LLC	33ed4e35-8be2-d0ea-e063-6394a90a06a6	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076697 application number: ANDA076697
Carbamazepine	CARBAMAZEPINE	Coupler LLC	33edb22f-f357-ec0f-e063-6394a90a7bc3	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076697 application number: ANDA076697
Carbamazepine	CARBAMAZEPINE	Coupler LLC	2d936849-9c80-5b7f-e063-6294a90aaa6c	2025-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076697 application number: ANDA076697

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
388311	carBAMazepine 100 MG 12HR Extended Release Oral Capsule	PSN	fbca2152-0022-47a5-a1ea-58950b45bcbf	10
200133	carBAMazepine 200 MG 12HR Extended Release Oral Capsule	PSN	fbca2152-0022-47a5-a1ea-58950b45bcbf	10
200131	carBAMazepine 300 MG 12HR Extended Release Oral Capsule	PSN	fbca2152-0022-47a5-a1ea-58950b45bcbf	10
388311	12 HR carbamazepine 100 MG Extended Release Oral Capsule	SCD	fbca2152-0022-47a5-a1ea-58950b45bcbf	10
200133	12 HR carbamazepine 200 MG Extended Release Oral Capsule	SCD	fbca2152-0022-47a5-a1ea-58950b45bcbf	10
200131	12 HR carbamazepine 300 MG Extended Release Oral Capsule	SCD	fbca2152-0022-47a5-a1ea-58950b45bcbf	10
388311	carbamazepine 100 MG 12 HR Extended Release Oral Capsule	SY	fbca2152-0022-47a5-a1ea-58950b45bcbf	10
200133	carbamazepine 200 MG 12 HR Extended Release Oral Capsule	SY	fbca2152-0022-47a5-a1ea-58950b45bcbf	10
200131	carbamazepine 300 MG 12 HR Extended Release Oral Capsule	SY	fbca2152-0022-47a5-a1ea-58950b45bcbf	10
388311	carBAMazepine 100 MG 12HR Extended Release Oral Capsule	PSN	33ed4e35-8be2-d0ea-e063-6394a90a06a6	1
388311	12 HR carbamazepine 100 MG Extended Release Oral Capsule	SCD	33ed4e35-8be2-d0ea-e063-6394a90a06a6	1
388311	carbamazepine 100 MG 12 HR Extended Release Oral Capsule	SY	33ed4e35-8be2-d0ea-e063-6394a90a06a6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
29033-019-12	29033001912	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29033-019-12)	2020-02-17	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 Rx only	Coupler LLC \| Nostrum Laboratories, Inc.	2025-04-29	HUMAN PRESCRIPTION DRUG LABEL	1
Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx only	Nostrum Laboratories, Inc.	2024-02-15	HUMAN PRESCRIPTION DRUG LABEL	10