FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
72485-109
11-digit product format
724850109
Labeler code
72485
Product ID
72485-109_e0530bba-ed48-45e7-ad3e-5d2b3f16a04f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA211370
Marketing category
ANDA
Marketing start
2020-01-01
Substance
VERAPAMIL HYDROCHLORIDE
Active strength
10 mg/4mL
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 HYDROCHLORIDE10 mg/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV3888OEY5R
Rxcui1665061

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
72485-109-01Verapamil Hydrochloride4 mL in 1 VIALINJECTION41
72485-109-05Verapamil Hydrochloride5 in 1 CARTONINJECTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-109-01ML - Milliliter72485-109c0f76d33-4a43-497e-aa86-b2377a5d74d112020-02-13
72485-109-05ML - Milliliter72485-1091fc856c8-7271-4f27-a555-9f440227f28212020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-109VERAPAMIL HYDROCHLORIDE INJECTION [ARMAS PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20200111_2d595d9d-af88-474d-b622-d63d786f06a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665061verapamil HCl 10 MG in 4 ML InjectionPSN2d595d9d-af88-474d-b622-d63d786f06a71
16650614 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD2d595d9d-af88-474d-b622-d63d786f06a71
1665061verapamil HCl 10 MG per 4 ML InjectionSY2d595d9d-af88-474d-b622-d63d786f06a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72485-109-01724850109014 mL in 1 VIAL4 mlHistorical
72485-109-05724850109055 VIAL in 1 CARTON (72485-109-05) / 4 mL in 1 VIAL (72485-109-01) 5 vial2020-01-010000-00-00NoNoCurrent