Carbamazepine

Product NDC: 0781-8016
11-digit product format: 007818016
Labeler code: 0781
Product ID: 0781-8016_7a606a30-c4f8-4694-9642-edb8e3cf5eee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Sandoz Inc
Application: NDA020234
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1996-03-25
Marketing end: 0000-00-00
Substance: CARBAMAZEPINE
Active strength: 100 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0781-8016		D	Discontinued by firm		2026-08-11
excluded package	package	0781-8016	0781-8016-01	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 · 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 product	product	0781-8016		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-8016	0781-8016-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020234-001	TEGRETOL-XR	CARBAMAZEPINE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25
N020234-002	TEGRETOL-XR	CARBAMAZEPINE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25
N020234-003	TEGRETOL-XR	CARBAMAZEPINE	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020234-001	AB
N020234-002	AB
N020234-003	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 4 · 123 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	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020234-002	TEGRETOL-XR	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020234-003	TEGRETOL-XR	400MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020234-001	TEGRETOL-XR	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-03-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N020234-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020234-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020234-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020234-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020234-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020234-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020234-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020234-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020234-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020234-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020234-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020234-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020234-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020234-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020234-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020234-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020234-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020234-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020234-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020234-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020234-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020234-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020234-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020234-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020234-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020234-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020234-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020234-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020234-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020234-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020234-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020234-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020234-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020234-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020234-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020234-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020234-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020234-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020234-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020234-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-8016-01	EA - Each	0781-8016	8dcbb955-711a-4512-b939-fd052be6506c	1	2018-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC]	6
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC]	6
DEXTRATES	INACTIVE INGREDIENT	G263MI44RU	CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-8016	CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [SANDOZ INC]	23	Legacy NDC	20221208_3a3344dc-9cc8-41da-859e-295d053597c1.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tegretol	CARBAMAZEPINE	Novartis Pharmaceuticals Corporation	8d409411-aa9f-4f3a-a52c-fbcb0c3ec053	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020234 application number: NDA020234

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	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-8016-01	00781801601	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8016-01)	2018-01-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbamazepine Extended-Release Tablets, USP	Sandoz Inc	2020-03-18	HUMAN PRESCRIPTION DRUG LABEL	23