FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
51079-917
11-digit product format
510790917
Labeler code
51079
Product ID
51079-917_3a87770c-fa53-d061-e063-6294a90a6751
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA075138
Marketing category
ANDA
Marketing start
1999-10-01
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VERAPAMIL HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV3888OEY5R
Rxcui897612

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea1f6fc8-bfc2-4421-a2eb-4e87c7c3e3c4Product name220230103
33ad674d-d105-6aa5-02fa-95ae4329b8cdProduct name220180809
3279bd6d-5b02-e60b-3857-c853a2deb2ddProduct name220170713
8ebb66e3-d7b3-f1e5-88aa-3369e64bb84aProduct name120140508
940a1faa-2df8-cc65-be37-1b97984b4ea3Product name120140508
d3b67bc2-0e96-e3ec-06a9-90afcc07bf13Product name120140508
e2fcd66c-a043-3187-790d-b0342deb1149Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51079-917-01Verapamil Hydrochloride1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE117
51079-917-20Verapamil Hydrochloride100 in 1 CARTONCAPSULE, EXTENDED RELEASE10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-917-01EA - Each51079-91782ac627b-2689-4734-81c7-9f9bd38bde9c12012-07-24
51079-917-20EA - Each51079-917b4570dfc-28f5-4e04-b6cf-f4c455336ec912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VERAPAMIL HYDROCHLORIDEACTIVE INGREDIENTV3888OEY5RVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
VERAPAMILACTIVE MOIETYCJ0O37KU29VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
DIETHYL PHTHALATEINACTIVE INGREDIENTUF064M00AFVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
GELATININACTIVE INGREDIENT2G86QN327LVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-917VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]16Current NDC, Legacy NDC, 2 package rows20231228_3bee2d26-138c-4641-a217-a38d3d657461.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897612verapamil HCl 120 MG 24HR Extended Release Oral CapsulePSN3bee2d26-138c-4641-a217-a38d3d65746117
89761224 HR verapamil hydrochloride 120 MG Extended Release Oral CapsuleSCD3bee2d26-138c-4641-a217-a38d3d65746117
897612verapamil hydrochloride 120 MG 24HR Extended Release Oral CapsuleSY3bee2d26-138c-4641-a217-a38d3d65746117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-917-01510790917011 in 1 BLISTER PACKHistorical
51079-917-2051079091720100 BLISTER PACK in 1 CARTON (51079-917-20) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (51079-917-01) 100 blister pack1999-10-010000-00-00NoNoCurrent