FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
0591-2880
11-digit product format
005912880
Labeler code
0591
Product ID
0591-2880_319554df-fc0d-428a-9799-a352100f1ce9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Teva Pharmaceuticals Inc
Application
NDA019614
Marketing category
NDA
Marketing start
1990-05-29
Marketing end
2026-09-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Verapamil Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VERAPAMIL HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV3888OEY5R
Rxcui897624

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0591-2880-01Verapamil Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2880-01EA - Each0591-288079d08f29-16a2-4acf-b5a7-ada49df3ee5d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VERAPAMIL HYDROCHLORIDEACTIVE INGREDIENTV3888OEY5RVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
VERAPAMILACTIVE MOIETYCJ0O37KU29VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
FUMARIC ACIDINACTIVE INGREDIENT88XHZ13131VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [ACTAVIS PHARMA, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2880VERAPAMIL HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [TEVA PHARMACEUTICALS INC]10Current NDC, Legacy NDC, 1 package rows20221105_0742cf97-601b-4c13-a6c3-1a6a616ed292.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897624verapamil HCl 240 MG 24HR Extended Release Oral CapsulePSN0742cf97-601b-4c13-a6c3-1a6a616ed29211
89762424 HR verapamil hydrochloride 240 MG Extended Release Oral CapsuleSCD0742cf97-601b-4c13-a6c3-1a6a616ed29211
897624verapamil hydrochloride 240 MG 24HR Extended Release Oral CapsuleSY0742cf97-601b-4c13-a6c3-1a6a616ed29211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-2880-0100591288001100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0591-2880-01) 1990-05-292026-09-30NoNoCurrent