Carbamazepine

Product NDC: 66993-409
11-digit product format: 669930409
Labeler code: 66993
Product ID: 66993-409_711ea8fa-f21f-442f-9e10-2b0aa78ae8cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbamazepine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Prasco Laboratories
Application: NDA020712
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2011-12-15
Marketing end: 0000-00-00
Substance: CARBAMAZEPINE
Active strength: 300 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	66993-409		D	Discontinued by firm		2026-08-11
excluded package	package	66993-409	66993-409-32	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 · 4 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	66993-409-32	`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	66993-409-32	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
N020712-001	CARBATROL	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30
N020712-002	CARBATROL	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30
N020712-003	CARBATROL	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020712-001	AB
N020712-002	AB
N020712-003	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	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-002	CARBATROL	300MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-003	CARBATROL	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020712-001	CARBATROL	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-09-30	`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	N020712-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020712-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020712-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020712-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020712-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020712-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020712-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020712-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020712-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020712-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020712-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020712-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020712-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020712-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020712-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020712-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020712-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020712-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020712-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020712-001	AB	1	`8072bd15b7f6…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-409-32	EA - Each	66993-409	07954edb-1948-498b-98eb-574db7124b88	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [PRASCO LABORATORIES]	4
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [PRASCO LABORATORIES]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-409	CARBAMAZEPINE CAPSULE, EXTENDED RELEASE [PRASCO LABORATORIES]	14	Legacy NDC	20230609_7a1e523a-b377-43dc-b231-7591c4c888ea.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
Carbatrol	CARBAMAZEPINE	Takeda Pharmaceuticals America, Inc.	bc03e499-5bac-4293-bff4-6864153a624d	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020712 application number: NDA020712

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
200131	carBAMazepine 300 MG 12HR Extended Release Oral Capsule	PSN	de6b0fd5-11fe-4f19-90e6-54339be5c9fc	1
200131	12 HR carbamazepine 300 MG Extended Release Oral Capsule	SCD	de6b0fd5-11fe-4f19-90e6-54339be5c9fc	1
200131	carbamazepine 300 MG 12 HR Extended Release Oral Capsule	SY	de6b0fd5-11fe-4f19-90e6-54339be5c9fc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
66993-409-32	66993040932	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66993-409-32)	2011-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARBAMAZEPINE Extended-Release Capsules 100 mg, 200 mg and 300 mg	Prasco Laboratories \| Patheon Manufacturing Services LLC \| Jubilant Generics Limited	2025-06-09	HUMAN PRESCRIPTION DRUG LABEL	15
CARBAMAZEPINE Extended-Release Capsules 100 mg, 200 mg and 300 mg	REMEDYREPACK INC.	2019-02-05	HUMAN PRESCRIPTION DRUG LABEL	4
Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg	Avera McKennan Hospital	2016-01-08	HUMAN PRESCRIPTION DRUG LABEL	1