Carbamazepine

Product NDC: 21695-724
11-digit product format: 216950724
Labeler code: 21695
Product ID: 21695-724_fc51bad7-8a77-4c0e-9ff8-fa3474796d35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA074649
Marketing category: ANDA
Marketing start: 2009-07-01
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: E
Listing certified through: 2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-724		I	Inactivated by FDA	2026-10-15
excluded package	package	21695-724	21695-724-30	I	Inactivated by FDA	2026-10-15
excluded package	package	21695-724	21695-724-60	I	Inactivated by FDA	2026-10-15

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 2 · 66 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	21695-724-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-724-60	`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	21695-724-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-724-60	`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	21695-724-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-724-60	`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	21695-724-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-724-60	`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	21695-724-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-724-60	`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	21695-724-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-724-60	`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	21695-724-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-724-60	`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	21695-724-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-724-60	`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	21695-724-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-724-60	`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	21695-724-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-724-60	`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	21695-724-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-724-60	`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	21695-724-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-724-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-724-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-724-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-724-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-724-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-724-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-724-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-724-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-724-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-724-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-724-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-724-30	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-724-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-724-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-724-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-724-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-724-60	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A074649-001	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET / ORAL	AB		1996-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074649-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074649-001	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	1996-10-03	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A074649-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074649-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074649-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074649-001	AB	1	`a50c72e98297…`

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
21695-724-30	2019-09-24	C162847	48780-1	934fe258-4ba2-48b1-e053-8cdaa90a720a	CARBAMAZEPINE TABLETS USP 200 mg Rx only
21695-724-60	2019-09-24	C162847	48780-1	934fe258-4ba2-48b1-e053-8cdaa90a720a	CARBAMAZEPINE TABLETS USP 200 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-724-30	Carbamazepine	30 in 1 BOTTLE	TABLET	30		2
21695-724-60	Carbamazepine	60 in 1 BOTTLE	TABLET	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-724-30	EA - Each	21695-724	226f7077-a23b-43f0-81b0-ebea7280a244	1	2012-07-24
21695-724-60	EA - Each	21695-724	333523d1-69c9-485d-8ba4-2e34180f5ca2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]	2
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]	2
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-724	CARBAMAZEPINE TABLET [REBEL DISTRIBUTORS CORP]	2	Legacy NDC, 2 package rows	20111108_25cca2b1-9020-4d8a-bc22-b8063e57f9e1.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	A-S Medication Solutions	1dc2a4d3-2ebc-4c9b-a347-92acd9f231f2	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649
Carbamazepine	CARBAMAZEPINE	Golden State Medical Supply, Inc.	8a1ce79d-18ea-f30b-e053-2995a90ad1fb	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	2d2c5317-4072-477b-a4e2-f6765fc71657	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649
Carbamazepine	CARBAMAZEPINE	Aphena Pharma Solutions - Tennessee, LLC	697f3e5a-c84b-44a6-b9f3-15e7d9bb6395	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074649 application number: ANDA074649

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	25cca2b1-9020-4d8a-bc22-b8063e57f9e1	2
308979	carbamazepine 200 MG Oral Tablet	SCD	25cca2b1-9020-4d8a-bc22-b8063e57f9e1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-724-30	21695072430	30 in 1 BOTTLE	Historical
21695-724-60	21695072460	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARBAMAZEPINE TABLETS USP 200 mg Rx only	Rebel Distributors Corp	2011-01-04	HUMAN PRESCRIPTION DRUG LABEL	2