CARBAMAZEPINE

Product NDC: 71335-0462
Requested package NDC: 71335-0462-4
11-digit product format: 713350462
Labeler code: 71335
Product ID: 71335-0462_1a2949a1-23b9-4617-8448-fa071cbcd648
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARBAMAZEPINE
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077272
Marketing category: ANDA
Marketing start: 2009-10-23
Marketing end: 0000-00-00
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-0462	71335-0462-4	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 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 · 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…`

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
71335-0462-4	71335046204	120 TABLET in 1 BOTTLE (71335-0462-4)	120 tablet	2022-03-09	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	Bryant Ranch Prepack	2022-03-09	HUMAN PRESCRIPTION DRUG LABEL	7