FDA.reportPublic FDA data

verapamil hydrochloride

Product NDC
55289-723
11-digit product format
552890723
Labeler code
55289
Product ID
55289-723_47e39c2d-9144-24b3-e063-6294a90a04d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078906
Marketing category
ANDA
Marketing start
2009-09-17
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
240 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
verapamil hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VERAPAMIL HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV3888OEY5R
Rxcui897649

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
55289-723-30verapamil hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE3015
55289-723-90verapamil hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE9015
55289-723-93verapamil hydrochloride180 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE18015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-723-30EA - Each55289-7234e408687-143e-4fba-8949-170943ab85e412012-07-24
55289-723-90EA - Each55289-723c90cc7c1-cec9-4b8e-ab7c-bdb37a67173112012-07-24
55289-723-93EA - Each55289-7236cd6ee47-52b8-47dc-877d-b31df30812f712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VERAPAMIL HYDROCHLORIDEACTIVE INGREDIENTV3888OEY5RVERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4
VERAPAMILACTIVE MOIETYCJ0O37KU29VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AVERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EVERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQVERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-723VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 3 package rows20241012_3c215e6c-d85a-4102-a1c2-f00fa3169a55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897649verapamil HCl 240 MG Extended Release Oral TabletPSN3c215e6c-d85a-4102-a1c2-f00fa3169a5515
897649verapamil hydrochloride 240 MG Extended Release Oral TabletSCD3c215e6c-d85a-4102-a1c2-f00fa3169a5515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-723-305528907233030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-723-30) 2015-11-020000-00-00NoNoCurrent
55289-723-905528907239090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-723-90) 2015-11-020000-00-00NoNoCurrent
55289-723-9355289072393180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-723-93) 2015-11-020000-00-00NoNoCurrent