Epitol

Product NDC: 0093-0090
11-digit product format: 000930090
Labeler code: 0093
Product ID: 0093-0090_5c31da75-fc21-4ab2-9487-64169767ebd0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA070541
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 2026-07-31
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
Current FDA listing: Yes

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	0093-0090		D	Discontinued by firm		2026-08-03
excluded package	package	0093-0090	0093-0090-01	D	Discontinued by firm		2026-08-03

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070541-001	EPITOL	CARBAMAZEPINE	200MG	TABLET / ORAL	AB		1986-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070541-001	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 2 · 41 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	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070541-001	EPITOL	200MG	TABLET / ORAL	AB	1986-09-17	`cb3db0bc1861…`

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	A070541-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070541-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070541-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070541-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070541-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070541-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070541-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070541-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070541-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070541-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070541-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070541-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070541-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070541-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070541-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070541-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070541-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070541-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070541-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070541-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070541-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070541-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070541-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070541-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070541-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070541-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070541-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070541-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070541-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070541-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070541-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070541-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070541-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070541-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070541-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070541-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070541-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070541-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070541-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070541-001	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
8448f819-8511-2a70-1d0e-32e16eac918d	Product name	1	20140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-0090-01	Epitol	100 in 1 BOTTLE	TABLET	100		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-0090-01	EA - Each	0093-0090	690d4abb-c43f-4123-8c3f-1c3b1e102e78	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]	9
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]	9
ETHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	47MLB0F1MV	EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]	9
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA INC]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-0090	EPITOL (CARBAMAZEPINE) TABLET [TEVA PHARMACEUTICALS USA, INC.]	17	Current NDC, Legacy NDC, 1 package rows	20240331_32bbe864-7374-44da-8c6e-e733f0648243.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
Carbamazepine	CARBAMAZEPINE	Bryant Ranch Prepack	ebcffad6-da03-43f4-a75b-7de13e94bb7d	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070541 application number: ANDA070541

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
308979	carBAMazepine 200 MG Oral Tablet	PSN	32bbe864-7374-44da-8c6e-e733f0648243	18
211817	Epitol 200 MG Oral Tablet	PSN	32bbe864-7374-44da-8c6e-e733f0648243	18
211817	carbamazepine 200 MG Oral Tablet [Epitol]	SBD	32bbe864-7374-44da-8c6e-e733f0648243	18
308979	carbamazepine 200 MG Oral Tablet	SCD	32bbe864-7374-44da-8c6e-e733f0648243	18
211817	Epitol 200 MG Oral Tablet	SY	32bbe864-7374-44da-8c6e-e733f0648243	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-0090-01	00093009001	100 TABLET in 1 BOTTLE (0093-0090-01)	100 tablet	1990-09-30	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EPITOL ® (carbamazepine tablets, USP) 200 mg Rx only	Teva Pharmaceuticals USA, Inc.	2024-01-01	HUMAN PRESCRIPTION DRUG LABEL	18