FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
0378-6440
11-digit product format
003786440
Labeler code
0378
Product ID
0378-6440_c63ca9bc-5c77-4e53-8adf-9cfd16bfe012
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
verapamil hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA075138
Marketing category
ANDA
Marketing start
1999-05-20
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
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 HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV3888OEY5R
Rxcui897612, 897618, 897624

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
0378-6440-01Verapamil Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE10018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6440VERAPAMIL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]18Current NDC, Legacy NDC, 1 package rows20241211_c86084bc-33aa-eece-5a96-6c0dad2d1a32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897612verapamil HCl 120 MG 24HR Extended Release Oral CapsulePSNc86084bc-33aa-eece-5a96-6c0dad2d1a3218
897618verapamil HCl 180 MG 24HR Extended Release Oral CapsulePSNc86084bc-33aa-eece-5a96-6c0dad2d1a3218
897624verapamil HCl 240 MG 24HR Extended Release Oral CapsulePSNc86084bc-33aa-eece-5a96-6c0dad2d1a3218
89761224 HR verapamil hydrochloride 120 MG Extended Release Oral CapsuleSCDc86084bc-33aa-eece-5a96-6c0dad2d1a3218
89761824 HR verapamil hydrochloride 180 MG Extended Release Oral CapsuleSCDc86084bc-33aa-eece-5a96-6c0dad2d1a3218
89762424 HR verapamil hydrochloride 240 MG Extended Release Oral CapsuleSCDc86084bc-33aa-eece-5a96-6c0dad2d1a3218
897612verapamil hydrochloride 120 MG 24HR Extended Release Oral CapsuleSYc86084bc-33aa-eece-5a96-6c0dad2d1a3218
897618verapamil hydrochloride 180 MG 24 HR Extended Release Oral CapsuleSYc86084bc-33aa-eece-5a96-6c0dad2d1a3218
897624verapamil hydrochloride 240 MG 24HR Extended Release Oral CapsuleSYc86084bc-33aa-eece-5a96-6c0dad2d1a3218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-6440-0100378644001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6440-01) 1999-05-200000-00-00NoNoCurrent