FDA.reportPublic FDA data

Verapamil hydrochloride

Product NDC
68083-447
11-digit product format
680830447
Labeler code
68083
Product ID
68083-447_97d5fbfc-783f-4d2d-a178-1ac1ff0d6a55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA214361
Marketing category
ANDA
Marketing start
2020-10-15
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
2.5 mg/mL
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 HYDROCHLORIDE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV3888OEY5R
Rxcui1665057, 1665061

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
68083-447-25Verapamil hydrochloride25 in 1 CARTONINJECTION254
68083-447-25Verapamil hydrochloride2 mL in 1 VIALINJECTION24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-447VERAPAMIL HYDROCHLORIDE INJECTION [GLAND PHARMA LIMITED]4Current NDC, Legacy NDC, 2 package rows20201020_eb3c66f6-581f-422b-9ca2-9b877b323a33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665061verapamil HCl 10 MG in 4 ML InjectionPSNeb3c66f6-581f-422b-9ca2-9b877b323a334
1665057verapamil HCl 5 MG in 2 ML InjectionPSNeb3c66f6-581f-422b-9ca2-9b877b323a334
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCDeb3c66f6-581f-422b-9ca2-9b877b323a334
16650614 ML verapamil hydrochloride 2.5 MG/ML InjectionSCDeb3c66f6-581f-422b-9ca2-9b877b323a334
1665061verapamil HCl 10 MG per 4 ML InjectionSYeb3c66f6-581f-422b-9ca2-9b877b323a334
1665057verapamil HCl 5 MG per 2 ML InjectionSYeb3c66f6-581f-422b-9ca2-9b877b323a334

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-447-256808304472525 VIAL in 1 CARTON (68083-447-25) / 2 mL in 1 VIAL25 vial2020-10-150000-00-00NoNoCurrent