FDA.reportPublic FDA data

VERAPAMIL HYDROCHLORIDE

Product NDC
71209-047
11-digit product format
712090047
Labeler code
71209
Product ID
71209-047_d6b80b6c-59f6-4e63-bb8d-a29a77f4a0a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA206173
Marketing category
ANDA
Marketing start
2017-05-27
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, 897649, 897659

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
71209-047-05VERAPAMIL HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE10013
71209-047-10VERAPAMIL HYDROCHLORIDE500 in 1 BOTTLETABLET, EXTENDED RELEASE50013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-047VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE [CADILA PHARMACEUTICALS LIMITED]12Current NDC, Legacy NDC, 2 package rows20230101_5501208c-aa2b-47aa-89f7-87f4d4a73fd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897659verapamil HCl 120 MG Extended Release Oral TabletPSN5501208c-aa2b-47aa-89f7-87f4d4a73fd013
897640verapamil HCl 180 MG Extended Release Oral TabletPSN5501208c-aa2b-47aa-89f7-87f4d4a73fd013
897649verapamil HCl 240 MG Extended Release Oral TabletPSN5501208c-aa2b-47aa-89f7-87f4d4a73fd013
897659verapamil hydrochloride 120 MG Extended Release Oral TabletSCD5501208c-aa2b-47aa-89f7-87f4d4a73fd013
897640verapamil hydrochloride 180 MG Extended Release Oral TabletSCD5501208c-aa2b-47aa-89f7-87f4d4a73fd013
897649verapamil hydrochloride 240 MG Extended Release Oral TabletSCD5501208c-aa2b-47aa-89f7-87f4d4a73fd013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71209-047-0571209004705100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71209-047-05) 2017-05-270000-00-00NoNoCurrent
71209-047-1071209004710500 TABLET, EXTENDED RELEASE in 1 BOTTLE (71209-047-10) 2020-02-140000-00-00NoNoCurrent