FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
0591-0343
11-digit product format
005910343
Labeler code
0591
Product ID
0591-0343_98d6e01a-d15c-47b4-82ae-87705e8ed7a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA070995
Marketing category
ANDA
Marketing start
1986-10-01
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
80 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 HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV3888OEY5R
Rxcui897666, 897683, 897722

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
0591-0343-01Verapamil Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10016
0591-0343-05Verapamil Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50016
0591-0343-10Verapamil Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0343-01EA - Each0591-034336fe64ac-27db-4c54-92bf-cf7ebcc6207b12012-07-24
0591-0343-05EA - Each0591-0343a4b683c9-d9dd-4c38-adf6-d4a18b83983a12012-07-24
0591-0343-10EA - Each0591-03437e3b4740-8074-42d7-9f51-dd98973f314012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VERAPAMIL HYDROCHLORIDEACTIVE INGREDIENTV3888OEY5RVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]10
VERAPAMILACTIVE MOIETYCJ0O37KU29VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]10
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]10
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]10
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]10
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]10
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]10
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [WATSON LABORATORIES, INC.]10
VERAPAMIL HYDROCHLORIDEACTIVE INGREDIENTV3888OEY5RVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
VERAPAMILACTIVE MOIETYCJ0O37KU29VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
VERAPAMIL HYDROCHLORIDEACTIVE INGREDIENTV3888OEY5RVERAPAMIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
VERAPAMILACTIVE MOIETYCJ0O37KU29VERAPAMIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKVERAPAMIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVERAPAMIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PVERAPAMIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VERAPAMIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUVERAPAMIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVERAPAMIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVERAPAMIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVERAPAMIL HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0343VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]16Current NDC, Legacy NDC, 3 package rows20241222_a0343397-897b-46d6-943f-a87e07e1de10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897666verapamil HCl 120 MG Oral TabletPSNa0343397-897b-46d6-943f-a87e07e1de1016
897722verapamil HCl 40 MG Oral TabletPSNa0343397-897b-46d6-943f-a87e07e1de1016
897683verapamil HCl 80 MG Oral TabletPSNa0343397-897b-46d6-943f-a87e07e1de1016
897666verapamil hydrochloride 120 MG Oral TabletSCDa0343397-897b-46d6-943f-a87e07e1de1016
897722verapamil hydrochloride 40 MG Oral TabletSCDa0343397-897b-46d6-943f-a87e07e1de1016
897683verapamil hydrochloride 80 MG Oral TabletSCDa0343397-897b-46d6-943f-a87e07e1de1016
897666verapamil HCl 120 MG Oral TabletPSNc9d71191-b32a-44f9-bc5a-283a06884c824
897722verapamil HCl 40 MG Oral TabletPSNc9d71191-b32a-44f9-bc5a-283a06884c824
897683verapamil HCl 80 MG Oral TabletPSNc9d71191-b32a-44f9-bc5a-283a06884c824
897666verapamil hydrochloride 120 MG Oral TabletSCDc9d71191-b32a-44f9-bc5a-283a06884c824
897722verapamil hydrochloride 40 MG Oral TabletSCDc9d71191-b32a-44f9-bc5a-283a06884c824
897683verapamil hydrochloride 80 MG Oral TabletSCDc9d71191-b32a-44f9-bc5a-283a06884c824
897666verapamil HCl 120 MG Oral TabletPSN90841684-4f00-450f-b366-6fc914ca8c541
897683verapamil HCl 80 MG Oral TabletPSN90841684-4f00-450f-b366-6fc914ca8c541
897666verapamil hydrochloride 120 MG Oral TabletSCD90841684-4f00-450f-b366-6fc914ca8c541
897683verapamil hydrochloride 80 MG Oral TabletSCD90841684-4f00-450f-b366-6fc914ca8c541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-0343-000059103430044000 TABLET, FILM COATED in 1 BAG (0591-0343-00)01-OCT-86Current
0591-0343-0100591034301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0343-01) 1986-10-010000-00-00NoNoCurrent
0591-0343-0500591034305500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0343-05) 1986-10-010000-00-00NoNoCurrent
0591-0343-10005910343101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0343-10) 1986-10-010000-00-00NoNoCurrent
0591-0343-770059103437752692 TABLET, FILM COATED in 1 CONTAINER (0591-0343-77)04-JUL-24Current