FDA.reportPublic FDA data

verapamil hydrochloride

Product NDC
51655-956
11-digit product format
516550956
Labeler code
51655
Product ID
51655-956_4a90a3e1-cfbb-4158-e063-6294a90a55c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078906
Marketing category
ANDA
Marketing start
2014-05-27
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-956-522024-07-25C16284748780-19d75b9d1-001e-f424-e053-dadaa90a57ceVerapamil Hydrochloride Extended-Release Tablets, USP
51655-956-522020-01-31C16284748780-19d75b9d1-001e-f424-e053-dadaa90a57ceVerapamil Hydrochloride Extended-Release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-956-26verapamil hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE905
51655-956-52verapamil hydrochloride30 in 1 BOTTLE, DISPENSINGTABLET, FILM COATED, EXTENDED RE305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VERAPAMIL HYDROCHLORIDEACTIVE INGREDIENTV3888OEY5RVERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS]1
VERAPAMILACTIVE MOIETYCJ0O37KU29VERAPAMIL HYDROCHLORIDE (VERAPAMIL HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-956VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 2 package rows20240725_62c3aadf-412e-41a5-9e57-2c48d962f90a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897649verapamil HCl 240 MG Extended Release Oral TabletPSN62c3aadf-412e-41a5-9e57-2c48d962f90a5
897649verapamil hydrochloride 240 MG Extended Release Oral TabletSCD62c3aadf-412e-41a5-9e57-2c48d962f90a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-956-265165509562690 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-956-26) 2023-05-18NoNoCurrent
51655-956-525165509565230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, DISPENSING (51655-956-52) 2014-05-27NoNoCurrent