FDA.reportPublic FDA data

EQUETRO

Product NDC
30698-419
11-digit product format
306980419
Labeler code
30698
Product ID
30698-419_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
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBAMAZEPINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii33CM23913M
Rxcui200131, 200133, 388311, 672908, 672909, 672910

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26452c40-1589-928d-2fae-b84a1d1cf183Product name920251105
2275add5-bc9e-431c-8e27-74c11f3127d5Product name120200728
7c710123-0208-426b-be07-b37720f2767dProduct name120161206
8448f819-8511-2a70-1d0e-32e16eac918dProduct name120140508
fee3eefd-cade-4e53-89b7-9d28964e1bc7Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30698-419-122025-08-19C16284748780-12cef2736-5ed0-d83d-e063-dadaa90ab31fThese 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
30698-419-122025-01-30C16284748780-12cef2736-5ed0-d83d-e063-dadaa90ab31fThese 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 NDCProductDescriptionFormQuantityStrengthSPL version
30698-419-12EQUETRO120 in 1 BOTTLECAPSULE, EXTENDED RELEASE12010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30698-419-12EA - Each30698-419f3f4838c-766a-402f-ad8a-3c1724841f8c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMAZEPINEACTIVE INGREDIENT33CM23913MEQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4
CARBAMAZEPINEACTIVE MOIETY33CM23913MEQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPEQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKEQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4
GELATININACTIVE INGREDIENT2G86QN327LEQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EEQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMEQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30698-419EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC]9Current NDC, Legacy NDC, 1 package rows20230113_be478f3c-40f6-47cc-8ab9-f420a9372b1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
388311carBAMazepine 100 MG 12HR Extended Release Oral CapsulePSNbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
200133carBAMazepine 200 MG 12HR Extended Release Oral CapsulePSNbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
200131carBAMazepine 300 MG 12HR Extended Release Oral CapsulePSNbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
672908Equetro 100 MG 12HR Extended Release Oral CapsulePSNbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
672910Equetro 200 MG 12HR Extended Release Oral CapsulePSNbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
672909Equetro 300 MG 12HR Extended Release Oral CapsulePSNbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
67290812 HR carbamazepine 100 MG Extended Release Oral Capsule [Equetro]SBDbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
67291012 HR carbamazepine 200 MG Extended Release Oral Capsule [Equetro]SBDbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
67290912 HR carbamazepine 300 MG Extended Release Oral Capsule [Equetro]SBDbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
38831112 HR carbamazepine 100 MG Extended Release Oral CapsuleSCDbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
20013312 HR carbamazepine 200 MG Extended Release Oral CapsuleSCDbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
20013112 HR carbamazepine 300 MG Extended Release Oral CapsuleSCDbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
67290812 HR Equetro 100 MG Extended Release Oral CapsuleSYbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
67291012 HR Equetro 200 MG Extended Release Oral CapsuleSYbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
67290912 HR Equetro 300 MG Extended Release Oral CapsuleSYbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
388311carbamazepine 100 MG 12 HR Extended Release Oral CapsuleSYbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
200133carbamazepine 200 MG 12 HR Extended Release Oral CapsuleSYbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
200131carbamazepine 300 MG 12 HR Extended Release Oral CapsuleSYbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
672908Equetro 100 MG 12 HR Extended Release Oral CapsuleSYbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
672910Equetro 200 MG 12 HR Extended Release Oral CapsuleSYbe478f3c-40f6-47cc-8ab9-f420a9372b1c10
672909Equetro 300 MG 12 HR Extended Release Oral CapsuleSYbe478f3c-40f6-47cc-8ab9-f420a9372b1c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
30698-419-1230698041912120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (30698-419-12) 2004-12-100000-00-00NoNoCurrent