FDA.reportPublic FDA data

verapamil hydrochloride

Product NDC
51655-959
11-digit product format
516550959
Labeler code
51655
Product ID
51655-959_4a90e257-f575-3ee4-e063-6294a90ade32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA090700
Marketing category
ANDA
Marketing start
2023-01-31
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
51655-959-52verapamil hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-959VERAPAMIL HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 1 package rows20230404_f7814f9a-e589-4041-e053-6294a90a29e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897640verapamil HCl 180 MG Extended Release Oral TabletPSNf7814f9a-e589-4041-e053-6294a90a29e33
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCDf7814f9a-e589-4041-e053-6294a90a29e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-959-525165509595230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-959-52) 2023-01-31NoNoCurrent