EQUETRO

Product NDC: 30698-421
11-digit product format: 306980421
Labeler code: 30698
Product ID: 30698-421_3cbb63f0-feee-fc41-e063-6294a90a5d40
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbamazepine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Validus Pharmaceuticals LLC
Application: NDA021710
Marketing category: NDA
Marketing start: 2004-12-10
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: 2026-12-31
Current FDA listing: Yes

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 · 14 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
2025-04-01 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	30698-421-12	I	Inactivated by FDA	`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	30698-421-12	I	Inactivated by FDA	`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	30698-421-12	I	Inactivated by FDA	`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	30698-421-12	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	30698-421-12	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	30698-421-12	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	30698-421-12	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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	RLD / RS	Approval date
N021710-001	EQUETRO	CARBAMAZEPINE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10
N021710-002	EQUETRO	CARBAMAZEPINE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10
N021710-003	EQUETRO	CARBAMAZEPINE	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021710-002	EQUETRO	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021710-003	EQUETRO	300MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2004-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021710-001	EQUETRO	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2004-12-10	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021710-001	6977253	2024-05-19	U-693	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021710-002	6977253	2024-05-19	U-693	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021710-003	6977253	2024-05-19	U-693	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021710-001	6977253	2024-05-19	U-693	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021710-002	6977253	2024-05-19	U-693	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021710-003	6977253	2024-05-19	U-693	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021710-001	6977253	2024-05-19	U-693	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021710-002	6977253	2024-05-19	U-693	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021710-003	6977253	2024-05-19	U-693	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021710-001	6977253	2024-05-19	U-693	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021710-002	6977253	2024-05-19	U-693	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021710-003	6977253	2024-05-19	U-693	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021710-001	6977253	2024-05-19	U-693	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021710-002	6977253	2024-05-19	U-693	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021710-003	6977253	2024-05-19	U-693	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021710-001	6977253	2024-05-19	U-693	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021710-002	6977253	2024-05-19	U-693	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021710-003	6977253	2024-05-19	U-693	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021710-001	6977253	2024-05-19	U-693	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021710-002	6977253	2024-05-19	U-693	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021710-003	6977253	2024-05-19	U-693	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021710-001	6977253	2024-05-19	U-693	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021710-002	6977253	2024-05-19	U-693	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021710-003	6977253	2024-05-19	U-693	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021710-001	6977253	2024-05-19	U-693	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021710-002	6977253	2024-05-19	U-693	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021710-003	6977253	2024-05-19	U-693	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021710-001	6977253	2024-05-19	U-693	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021710-002	6977253	2024-05-19	U-693	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021710-003	6977253	2024-05-19	U-693	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021710-001	6977253	2024-05-19	U-693	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021710-002	6977253	2024-05-19	U-693	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021710-003	6977253	2024-05-19	U-693	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021710-001	6977253	2024-05-19	U-693	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021710-002	6977253	2024-05-19	U-693	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021710-003	6977253	2024-05-19	U-693	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021710-001	6977253	2024-05-19	U-693	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021710-002	6977253	2024-05-19	U-693	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021710-003	6977253	2024-05-19	U-693	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021710-001	6977253	2024-05-19	U-693	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: EQUETRO
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBAMAZEPINE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
33CM23913M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200131	Internal RxNorm lookup
200133	Internal RxNorm lookup
388311	Internal RxNorm lookup
672908	Internal RxNorm lookup
672909	Internal RxNorm lookup
672910	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
be478f3c-40f6-47cc-8ab9-f420a9372b1c	Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
30698-421-12	2025-08-19	C162847	48780-1	2cef2736-5ed0-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use EQUETROn safely and effectively. See full prescribing information for EQUETRO. EQUETRO (carbamazepine) extended-release capsules, for oral use Initial U.S. Approval: 1968
30698-421-12	2025-01-30	C162847	48780-1	2cef2736-5ed0-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use EQUETROn safely and effectively. See full prescribing information for EQUETRO. EQUETRO (carbamazepine) extended-release capsules, for oral use Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
30698-421-12	EQUETRO	120 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	120		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
30698-421-12	EA - Each	30698-421	a0fe0a60-5c98-4239-9d78-09b552709698	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBAMAZEPINE	ACTIVE INGREDIENT	33CM23913M	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4
CARBAMAZEPINE	ACTIVE MOIETY	33CM23913M	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
30698-421	EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]	9	Current NDC, Legacy NDC, 1 package rows	20230113_be478f3c-40f6-47cc-8ab9-f420a9372b1c.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
EQUETRO	CARBAMAZEPINE	Validus Pharmaceuticals LLC	be478f3c-40f6-47cc-8ab9-f420a9372b1c	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021710 application number: NDA021710 ndc (product): 30698-421

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
388311	carBAMazepine 100 MG 12HR Extended Release Oral Capsule	PSN	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
200133	carBAMazepine 200 MG 12HR Extended Release Oral Capsule	PSN	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
200131	carBAMazepine 300 MG 12HR Extended Release Oral Capsule	PSN	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
672908	Equetro 100 MG 12HR Extended Release Oral Capsule	PSN	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
672910	Equetro 200 MG 12HR Extended Release Oral Capsule	PSN	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
672909	Equetro 300 MG 12HR Extended Release Oral Capsule	PSN	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
672908	12 HR carbamazepine 100 MG Extended Release Oral Capsule [Equetro]	SBD	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
672910	12 HR carbamazepine 200 MG Extended Release Oral Capsule [Equetro]	SBD	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
672909	12 HR carbamazepine 300 MG Extended Release Oral Capsule [Equetro]	SBD	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
388311	12 HR carbamazepine 100 MG Extended Release Oral Capsule	SCD	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
200133	12 HR carbamazepine 200 MG Extended Release Oral Capsule	SCD	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
200131	12 HR carbamazepine 300 MG Extended Release Oral Capsule	SCD	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
672908	12 HR Equetro 100 MG Extended Release Oral Capsule	SY	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
672910	12 HR Equetro 200 MG Extended Release Oral Capsule	SY	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
672909	12 HR Equetro 300 MG Extended Release Oral Capsule	SY	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
388311	carbamazepine 100 MG 12 HR Extended Release Oral Capsule	SY	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
200133	carbamazepine 200 MG 12 HR Extended Release Oral Capsule	SY	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
200131	carbamazepine 300 MG 12 HR Extended Release Oral Capsule	SY	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
672908	Equetro 100 MG 12 HR Extended Release Oral Capsule	SY	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
672910	Equetro 200 MG 12 HR Extended Release Oral Capsule	SY	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10
672909	Equetro 300 MG 12 HR Extended Release Oral Capsule	SY	be478f3c-40f6-47cc-8ab9-f420a9372b1c	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
30698-421-12	30698042112	120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (30698-421-12)	2004-12-10	0000-00-00	No	No	Current