FDA.reportPublic FDA data

VERAPAMIL HYDROCHLORIDE

Product NDC
50090-5253
11-digit product format
500905253
Labeler code
50090
Product ID
50090-5253_caca7395-7eaa-4d05-bd4b-fb92e997f480
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VERAPAMIL HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206173
Marketing category
ANDA
Marketing start
2019-05-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VERAPAMIL HYDROCHLORIDE
Listing expiration
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5253-42023-02-07C16284748780-1f386c64a-00c3-0266-e053-dadaa90a7c1aVERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP Extended Release Film Coated Tablets
50090-5253-42023-01-30C16284748780-1f386c64a-00c3-0266-e053-dadaa90a7c1aVERAPAMIL HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP Extended Release Film Coated Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5253-4VERAPAMIL HYDROCHLORIDE30 in 1 BOTTLETABLET309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5253-4EA - Each50090-5253cb99a72d-a7f3-437d-95f2-3543f2a752e312023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5253VERAPAMIL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 1 package rows20230613_5467dad4-f3ba-4036-b5f4-4d2d4d5abc34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897640verapamil HCl 180 MG Extended Release Oral TabletPSN5467dad4-f3ba-4036-b5f4-4d2d4d5abc349
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCD5467dad4-f3ba-4036-b5f4-4d2d4d5abc349

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5253-45009052530430 TABLET in 1 BOTTLE (50090-5253-4) 30 tablet2020-10-140000-00-00NoNoCurrent