CARBAMAZEPINE

Product NDC: 60505-0183
11-digit product format: 605050183
Labeler code: 60505
Product ID: 60505-0183_e6a60bd5-3bd4-783c-7fb0-25fee964d387
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARBAMAZEPINE
Dosage form: TABLET
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA075948
Marketing category: ANDA
Marketing start: 2002-09-01
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

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	60505-0183	60505-0183-5	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

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

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
A075948-001	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET / ORAL	AB		2002-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075948-001	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	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075948-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2002-02-27	`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	A075948-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075948-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075948-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075948-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075948-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075948-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075948-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075948-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075948-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075948-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075948-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075948-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075948-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075948-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075948-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075948-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075948-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075948-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075948-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075948-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075948-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075948-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075948-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075948-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075948-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075948-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075948-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075948-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075948-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075948-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075948-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075948-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075948-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075948-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075948-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075948-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075948-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075948-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075948-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075948-001	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
bf0d012f-da14-8ce3-d74f-56172cddebc5	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
60505-0183-0	CARBAMAZEPINE	100 in 1 BOTTLE	TABLET	100	20
60505-0183-1	CARBAMAZEPINE	1000 in 1 BOTTLE	TABLET	1000	20
60505-0183-5	CARBAMAZEPINE	500 in 1 BOTTLE	TABLET	500	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0183-0	EA - Each	60505-0183	22e3a572-b45e-4e44-ba52-b2b381b619ea	1	2012-07-24
60505-0183-1	EA - Each	60505-0183	09301317-1e9a-4408-b724-90fe516c7baa	1	2012-07-24
60505-0183-5	EA - Each	60505-0183	bcc23229-5588-4f23-a06c-02c3a8a72310	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET [APOTEX CORP.]	8
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET [APOTEX CORP.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARBAMAZEPINE TABLET [APOTEX CORP.]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CARBAMAZEPINE TABLET [APOTEX CORP.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET [APOTEX CORP.]	8
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET [AMERICAN HEALTH PACKAGING]	2
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET [AMERICAN HEALTH PACKAGING]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARBAMAZEPINE TABLET [AMERICAN HEALTH PACKAGING]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CARBAMAZEPINE TABLET [AMERICAN HEALTH PACKAGING]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET [AMERICAN HEALTH PACKAGING]	2
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ETHYLCELLULOSE	INACTIVE INGREDIENT	7Z8S9VYZ4B	CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0183	CARBAMAZEPINE TABLET [APOTEX CORP.]	18	Current NDC, Legacy NDC, 3 package rows	20240206_bf0d012f-da14-8ce3-d74f-56172cddebc5.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBAMAZEPINE	CARBAMAZEPINE	REMEDYREPACK INC.	52cf3ba9-0a7c-4809-830e-af93d1532726	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075948 application number: ANDA075948
CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	34f57a68-57ad-57f1-e063-6394a90a3d33	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075948 application number: ANDA075948
CARBAMAZEPINE	CARBAMAZEPINE	Preferred Pharmaceuticals Inc.	32dc301e-881d-47b0-ad16-f9ff31d19324	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075948 application number: ANDA075948
CARBAMAZEPINE	CARBAMAZEPINE	Golden State Medical Supply, Inc.	9fca7d59-dd9e-4fd8-bf34-e2f7e5a36801	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075948 application number: ANDA075948
CARBAMAZEPINE	CARBAMAZEPINE	Apotex Corp.	bf0d012f-da14-8ce3-d74f-56172cddebc5	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075948 application number: ANDA075948 ndc (product): 60505-0183
CARBAMAZEPINE	CARBAMAZEPINE	Bryant Ranch Prepack	45b355e6-9c19-4138-a1f8-53508e88f5a9	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075948 application number: ANDA075948
Carbamazepine	CARBAMAZEPINE	American Health Packaging	1dd3d934-efee-4fdb-ae6f-f47b61831a2e	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075948 application number: ANDA075948
CARBAMAZEPINE	CARBAMAZEPINE	Proficient Rx LP	bf61798e-c07e-4959-909a-2b4c2c83b532	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075948 application number: ANDA075948
CARBAMAZEPINE	CARBAMAZEPINE	Aphena Pharma Solutions - Tennessee, LLC	c1fc31ef-6b2e-4de4-a185-ec44e94e7b40	2016-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075948 application number: ANDA075948

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	34f57a68-57ad-57f1-e063-6394a90a3d33	101
308979	carbamazepine 200 MG Oral Tablet	SCD	34f57a68-57ad-57f1-e063-6394a90a3d33	101
308979	carBAMazepine 200 MG Oral Tablet	PSN	bf0d012f-da14-8ce3-d74f-56172cddebc5	20
308979	carbamazepine 200 MG Oral Tablet	SCD	bf0d012f-da14-8ce3-d74f-56172cddebc5	20
308979	carBAMazepine 200 MG Oral Tablet	PSN	9fca7d59-dd9e-4fd8-bf34-e2f7e5a36801	13
308979	carbamazepine 200 MG Oral Tablet	SCD	9fca7d59-dd9e-4fd8-bf34-e2f7e5a36801	13
308979	carBAMazepine 200 MG Oral Tablet	PSN	32dc301e-881d-47b0-ad16-f9ff31d19324	9
308979	carBAMazepine 200 MG Oral Tablet	PSN	45b355e6-9c19-4138-a1f8-53508e88f5a9	9
308979	carBAMazepine 200 MG Oral Tablet	PSN	52cf3ba9-0a7c-4809-830e-af93d1532726	9
308979	carbamazepine 200 MG Oral Tablet	SCD	45b355e6-9c19-4138-a1f8-53508e88f5a9	9
308979	carbamazepine 200 MG Oral Tablet	SCD	52cf3ba9-0a7c-4809-830e-af93d1532726	9
308979	carbamazepine 200 MG Oral Tablet	SCD	32dc301e-881d-47b0-ad16-f9ff31d19324	9
308979	carBAMazepine 200 MG Oral Tablet	PSN	3554a0b6-ea96-4516-81d7-cc2d27b4fc33	8
308979	carbamazepine 200 MG Oral Tablet	SCD	3554a0b6-ea96-4516-81d7-cc2d27b4fc33	8
308979	carBAMazepine 200 MG Oral Tablet	PSN	1dd3d934-efee-4fdb-ae6f-f47b61831a2e	7
308979	carbamazepine 200 MG Oral Tablet	SCD	1dd3d934-efee-4fdb-ae6f-f47b61831a2e	7
308979	carBAMazepine 200 MG Oral Tablet	PSN	bf61798e-c07e-4959-909a-2b4c2c83b532	3
308979	carbamazepine 200 MG Oral Tablet	SCD	bf61798e-c07e-4959-909a-2b4c2c83b532	3
308979	carBAMazepine 200 MG Oral Tablet	PSN	88dd818c-80b5-a85c-e053-2a95a90aa84d	2
308979	carbamazepine 200 MG Oral Tablet	SCD	88dd818c-80b5-a85c-e053-2a95a90aa84d	2
197441	carBAMazepine 100 MG Oral Tablet	PSN	6903e7ef-8b5c-4b64-a87d-62f1f102bc75	1
308979	carBAMazepine 200 MG Oral Tablet	PSN	6903e7ef-8b5c-4b64-a87d-62f1f102bc75	1
197441	carbamazepine 100 MG Oral Tablet	SCD	6903e7ef-8b5c-4b64-a87d-62f1f102bc75	1
308979	carbamazepine 200 MG Oral Tablet	SCD	6903e7ef-8b5c-4b64-a87d-62f1f102bc75	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0183-0	60505018300	100 TABLET in 1 BOTTLE (60505-0183-0)	100 tablet	2002-09-01	0000-00-00	No	No	Current
60505-0183-1	60505018301	1000 TABLET in 1 BOTTLE (60505-0183-1)	1000 tablet	2002-09-01	0000-00-00	No	No	Current
60505-0183-5	60505018305	500 TABLET in 1 BOTTLE (60505-0183-5)	500 tablet	2002-09-01	2023-01-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information	REMEDYREPACK INC.	2026-08-04	HUMAN PRESCRIPTION DRUG LABEL	10
CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information	Bryant Ranch Prepack	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	101
CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information	Preferred Pharmaceuticals Inc.	2026-03-20	HUMAN PRESCRIPTION DRUG LABEL	9
CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information	Golden State Medical Supply, Inc.	2025-11-25	HUMAN PRESCRIPTION DRUG LABEL	13
CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information	Apotex Corp.	2025-10-10	HUMAN PRESCRIPTION DRUG LABEL	20
CARBAMAZEPINE TABLETS, USP 200 mg	Bryant Ranch Prepack	2025-07-28	HUMAN PRESCRIPTION DRUG LABEL	9
Carbamazepine Tablets, USP 8244401/1024 Rx Only Prescribing Information	American Health Packaging	2024-10-22	HUMAN PRESCRIPTION DRUG LABEL	7
CARBAMAZEPINE TABLETS, USP 200 mg	Bryant Ranch Prepack	2024-04-04	HUMAN PRESCRIPTION DRUG LABEL	106
CARBAMAZEPINE TABLETS, USP 200 mg	Bryant Ranch Prepack	2022-06-06	HUMAN PRESCRIPTION DRUG LABEL	100
CARBAMAZEPINE TABLETS, USP 200 mg	NuCare Pharmaceuticals,Inc.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	2
CARBAMAZEPINE 200mg	RedPharm Drug, Inc.	2021-01-13	HUMAN PRESCRIPTION DRUG LABEL	2
CARBAMAZEPINE TABLETS, USP 200 mg	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	8
CARBAMAZEPINE TABLETS, USP 200 mg	Proficient Rx LP	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	3
CARBAMAZEPINE	Northwind Pharmaceuticals, LLC	2015-03-23	HUMAN PRESCRIPTION DRUG LABEL	1
CARBAMAZEPINE TABLETS, USP	State of Florida DOH Central Pharmacy	2010-05-20	HUMAN PRESCRIPTION DRUG LABEL	1