FDA.reportPublic FDA data

verapamil hydrochloride

Product NDC
72789-416
11-digit product format
727890416
Labeler code
72789
Product ID
72789-416_47a9cf5c-f94f-a77e-e063-6294a90ad40d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090700
Marketing category
ANDA
Marketing start
2011-08-05
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
180 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 HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV3888OEY5R
Rxcui897640

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
72789-416-90verapamil hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-416VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]11Current NDC, 1 package rows20240620_9d529fe3-7b5c-4dde-9a8c-440a969df359.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897640verapamil HCl 180 MG Extended Release Oral TabletPSN9d529fe3-7b5c-4dde-9a8c-440a969df35913
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCD9d529fe3-7b5c-4dde-9a8c-440a969df35913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-416-907278904169090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-416-90) 2024-06-19NoNoCurrent