CARBAMAZEPINE

Product NDC: 58118-0268
11-digit product format: 581180268
Labeler code: 58118
Product ID: 58118-0268_ae7ecc37-9218-7746-e053-2995a90a675c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARBAMAZEPINE
Dosage form: TABLET
Route: ORAL
Labeler: Clinical Solutions Wholesale
Application: ANDA077272
Marketing category: ANDA
Marketing start: 2009-10-23
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: 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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	58118-0268		D	Discontinued by firm	2026-08-11
excluded package	package	58118-0268	58118-0268-0	D	Discontinued by firm	2026-08-11
excluded package	package	58118-0268	58118-0268-3	D	Discontinued by firm	2026-08-11
excluded package	package	58118-0268	58118-0268-6	D	Discontinued by firm	2026-08-11
excluded package	package	58118-0268	58118-0268-8	D	Discontinued by firm	2026-08-11
excluded package	package	58118-0268	58118-0268-9	D	Discontinued by firm	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 2 · 78 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58118-0268-3	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58118-0268-8	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58118-0268-9	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58118-0268-0	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58118-0268-6	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58118-0268-3	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58118-0268-8	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58118-0268-9	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58118-0268-0	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58118-0268-6	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58118-0268-3	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58118-0268-8	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58118-0268-9	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58118-0268-0	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58118-0268-6	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58118-0268-3	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58118-0268-8	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58118-0268-9	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58118-0268-0	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58118-0268-6	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58118-0268-3	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58118-0268-8	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58118-0268-9	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58118-0268-0	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58118-0268-6	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58118-0268-3	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58118-0268-8	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58118-0268-9	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58118-0268-0	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58118-0268-6	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58118-0268-3	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58118-0268-8	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58118-0268-9	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58118-0268-0	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58118-0268-6	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58118-0268-3	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58118-0268-8	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58118-0268-9	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58118-0268-0	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58118-0268-6	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58118-0268-3	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58118-0268-8	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58118-0268-9	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58118-0268-0	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58118-0268-6	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58118-0268-3	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58118-0268-8	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58118-0268-9	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58118-0268-0	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58118-0268-6	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077272-001	CARBAMAZEPINE	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07
A077272-002	CARBAMAZEPINE	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07
A077272-003	CARBAMAZEPINE	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07
A077272-004	CARBAMAZEPINE	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077272-002	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 5 · 164 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	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL		2005-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2005-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2005-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2005-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077272-001	CARBAMAZEPINE	100MG	TABLET / ORAL	AB	2005-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077272-002	CARBAMAZEPINE	200MG	TABLET / ORAL	AB	2005-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077272-003	CARBAMAZEPINE	300MG	TABLET / ORAL		2005-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077272-004	CARBAMAZEPINE	400MG	TABLET / ORAL		2005-12-07	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 71 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	A077272-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077272-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077272-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077272-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077272-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077272-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077272-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077272-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077272-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077272-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077272-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077272-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077272-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077272-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077272-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077272-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077272-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077272-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077272-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077272-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077272-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077272-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077272-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077272-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077272-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077272-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077272-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077272-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077272-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077272-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077272-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077272-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077272-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077272-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077272-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077272-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077272-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077272-001	AB	1	`c0c555d07b60…`

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
58118-0268-0	Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mg
58118-0268-3	Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mg
58118-0268-6	Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mg
58118-0268-8	Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mg
58118-0268-9	Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58118-0268	CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, CHEWABLE [CLINICAL SOLUTIONS WHOLESALE]	8	Legacy NDC	20200905_e36ece79-544b-43b2-8cf9-ca9861b071b5.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARBAMAZEPINE	CARBAMAZEPINE	Torrent Pharmaceuticals Limited	97e6e175-75e8-437b-b457-ddb1ae4e857d	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077272 application number: ANDA077272
CARBAMAZEPINE	CARBAMAZEPINE	Major Pharmaceuticals	2a8c7366-ce89-47ce-8123-96f26812fca0	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077272 application number: ANDA077272
Carbamazepine	CARBAMAZEPINE	Cardinal Health 107, LLC	232ef732-ee6d-4ac7-8e78-c619b611fbbe	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077272 application number: ANDA077272

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
33CM23913M	CARBAMAZEPINE	298-46-4	CARBAMAZEPINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58118-0268-8	58118026808	30 TABLET in 1 BLISTER PACK (58118-0268-8)	30 tablet	2009-10-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbamazepine Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine Tablets, USP (Chewable), 100 mg	Clinical Solutions Wholesale \| Clincal Solutions Wholesale	2020-09-04	HUMAN PRESCRIPTION DRUG LABEL	8