CARBAMAZEPINE

Product NDC: 70518-3146
11-digit product format: 705183146
Labeler code: 70518
Product ID: 70518-3146_51116fe8-6467-b482-e063-6294a90aa539
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARBAMAZEPINE
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA075948
Marketing category: ANDA
Marketing start: 2021-07-13
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: 2027-12-31
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	70518-3146	70518-3146-2	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 · 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	70518-3146	70518-3146-2	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-3146	70518-3146-2	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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: 2027-12-31

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
52cf3ba9-0a7c-4809-830e-af93d1532726	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#

Effective, Related label table
Effective	Related label
2023-02-13	CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-02-13	CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-02-13	CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-01-30	CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-01-30	CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information
2023-01-30	CARBAMAZEPINE TABLETS 200 mg Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-3146-0	CARBAMAZEPINE	100 in 1 BOX	TABLET	100	9
70518-3146-1	CARBAMAZEPINE	1 in 1 POUCH	TABLET	1	9
70518-3146-2	CARBAMAZEPINE	30 in 1 BLISTER PACK	TABLET	30	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-3146-0	EA - Each	70518-3146	68cc9f8e-df1e-49e0-a930-3e8a772fd2df	1	2026-01-08
70518-3146-1	EA - Each	70518-3146	aaf6b1af-d00c-424f-a0fc-e1c8f36f22e8	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3146	CARBAMAZEPINE TABLET [REMEDYREPACK INC.]	5	Current NDC, Legacy NDC, 3 package rows	20250424_52cf3ba9-0a7c-4809-830e-af93d1532726.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 ndc (product): 70518-3146
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
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	52cf3ba9-0a7c-4809-830e-af93d1532726	9
308979	carbamazepine 200 MG Oral Tablet	SCD	52cf3ba9-0a7c-4809-830e-af93d1532726	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3146-0	70518314600	100 POUCH in 1 BOX (70518-3146-0) / 1 TABLET in 1 POUCH (70518-3146-1)	100 pouch	2021-07-13	0000-00-00	No	No	Current
70518-3146-1	70518314601	1 in 1 POUCH						Historical
70518-3146-2	70518314602	30 in 1 BLISTER PACK						Historical

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