Carbamazepine

Product NDC: 68788-9812
11-digit product format: 687889812
Labeler code: 68788
Product ID: 68788-9812_b387be7e-e619-46b5-a7cc-2fcc0484e30a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc
Application: ANDA075687
Marketing category: ANDA
Marketing start: 2012-04-23
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-9812		I	Inactivated by FDA	2026-08-11
excluded package	package	68788-9812	68788-9812-1	I	Inactivated by FDA	2026-08-11
excluded package	package	68788-9812	68788-9812-2	I	Inactivated by FDA	2026-08-11
excluded package	package	68788-9812	68788-9812-3	I	Inactivated by FDA	2026-08-11
excluded package	package	68788-9812	68788-9812-6	I	Inactivated by FDA	2026-08-11
excluded package	package	68788-9812	68788-9812-9	I	Inactivated by FDA	2026-08-11

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 3 · 132 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	68788-9812-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9812-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9812-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9812-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-9812-3	`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	68788-9812-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9812-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9812-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9812-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-9812-3	`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	68788-9812-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9812-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9812-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9812-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-9812-3	`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	68788-9812-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9812-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9812-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9812-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-9812-3	`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	68788-9812-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9812-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9812-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9812-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-9812-3	`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	68788-9812-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9812-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9812-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9812-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-9812-3	`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	68788-9812-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9812-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9812-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9812-6	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-9812-3	`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	68788-9812-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9812-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9812-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9812-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-9812-3	`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	68788-9812-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9812-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9812-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9812-6	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-9812-3	`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	68788-9812-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9812-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9812-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9812-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-9812-3	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075687-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24
A075687-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075687-001	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB		2000-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075687-001	CARBAMAZEPINE	100MG	TABLET, CHEWABLE / ORAL	AB	RS	2000-10-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075687-002	CARBAMAZEPINE	200MG	TABLET, CHEWABLE / ORAL		RS	2002-07-29	`782e0a99824c…`

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	A075687-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075687-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075687-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075687-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075687-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075687-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075687-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075687-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075687-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075687-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075687-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075687-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075687-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075687-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075687-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075687-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075687-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075687-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075687-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075687-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075687-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075687-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075687-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075687-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075687-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075687-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075687-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075687-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075687-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075687-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075687-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075687-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075687-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075687-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075687-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075687-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075687-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075687-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075687-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075687-001	AB	1	`cb3db0bc1861…`

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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
8448f819-8511-2a70-1d0e-32e16eac918d	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
68788-9812-1	Carbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL
68788-9812-2	Carbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL
68788-9812-3	Carbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL
68788-9812-6	Carbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL
68788-9812-9	Carbamazepine Tablets USP, (chewable), 100 mg and 200 mg Carbamazepine Tablets USP, 200 mg Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg Carbamazepine Oral Suspension USP, 100 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-9812-1	Carbamazepine	100 in 1 BOTTLE	TABLET, CHEWABLE	100	3
68788-9812-2	Carbamazepine	20 in 1 BOTTLE	TABLET, CHEWABLE	20	3
68788-9812-3	Carbamazepine	30 in 1 BOTTLE	TABLET, CHEWABLE	30	3
68788-9812-6	Carbamazepine	60 in 1 BOTTLE	TABLET, CHEWABLE	60	3
68788-9812-9	Carbamazepine	90 in 1 BOTTLE	TABLET, CHEWABLE	90	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Carbamazepine	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]	3
Carbamazepine	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]	3
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]	3
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]	3
diethyl phthalate	INACTIVE INGREDIENT	UF064M00AF	CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]	3
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]	3
sorbitol	INACTIVE INGREDIENT	506T60A25R	CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]	3
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-9812	CARBAMAZEPINE TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC]	3	Legacy NDC, 5 package rows	20140402_157f67bd-74f0-4d68-9058-8fa707c564be.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	9471b7fb-29d3-4009-9d0f-f20c27351db5	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687
Carbamazepine	CARBAMAZEPINE	REMEDYREPACK INC.	d0121be3-b904-41d3-a81a-292aa4176491	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687
Carbamazepine	CARBAMAZEPINE	Golden State Medical Supply, Inc.	536811ab-308b-4866-9185-9e4149483512	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687
Carbamazepine	CARBAMAZEPINE	Sun Pharmaceutical Industries, Inc.	0526a054-3eda-49b4-b390-7d5d16e30af8	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687
Carbamazepine	CARBAMAZEPINE	NCS HealthCare of KY, LLC dba Vangard Labs	963db7cf-e9f5-496c-816e-626e89bc839e	2022-08-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075687 application number: ANDA075687

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
197442	carBAMazepine 200 MG Chewable Tablet	PSN	157f67bd-74f0-4d68-9058-8fa707c564be	3
197442	carbamazepine 200 MG Chewable Tablet	SCD	157f67bd-74f0-4d68-9058-8fa707c564be	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68788-9812-1	68788981201	100 in 1 BOTTLE	Historical
68788-9812-2	68788981202	20 in 1 BOTTLE	Historical
68788-9812-3	68788981203	30 in 1 BOTTLE	Historical
68788-9812-6	68788981206	60 in 1 BOTTLE	Historical
68788-9812-9	68788981209	90 in 1 BOTTLE	Historical