FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
51655-957
11-digit product format
516550957
Labeler code
51655
Product ID
51655-957_49749ad1-b3e5-3e64-e063-6294a90a2eee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA070994
Marketing category
ANDA
Marketing start
2020-06-01
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
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 HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV3888OEY5R
Rxcui897666

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
51655-957-262023-04-18C16284748780-1f386c64a-0efb-0266-e053-dadaa90a7c1aVerapamil Hydrochloride Tablets USP Rx only
51655-957-262023-01-30C16284748780-1f386c64a-0efb-0266-e053-dadaa90a7c1aVerapamil Hydrochloride Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-957-26Verapamil Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-957VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20240814_adc77fea-db39-aac5-e053-2995a90ad458.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897666verapamil HCl 120 MG Oral TabletPSNadc77fea-db39-aac5-e053-2995a90ad4585
897666verapamil hydrochloride 120 MG Oral TabletSCDadc77fea-db39-aac5-e053-2995a90ad4585

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-957-265165509572690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-957-26) 2020-06-010000-00-00NoNoCurrent