FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
65145-113
11-digit product format
651450113
Labeler code
65145
Product ID
65145-113_fb2643f1-42d0-410c-a4ab-b0a8ce457cfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA213232
Marketing category
ANDA
Marketing start
2025-01-16
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
65145-113-01Verapamil Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION25
65145-113-25Verapamil Hydrochloride25 in 1 CARTONINJECTION, SOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-113-01ML - Milliliter65145-1134d3f0175-970e-4d07-b71e-6674c8dd915212025-02-10
65145-113-25ML - Milliliter65145-1136832b86f-8e16-4a83-afc9-51ac4165088a12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-113VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION [CAPLIN STERILES LIMITED]5Current NDC, Legacy NDC, 2 package rows20250117_e18cc04c-a808-4d92-9b66-762cd787abc5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665061verapamil HCl 10 MG in 4 ML InjectionPSNe18cc04c-a808-4d92-9b66-762cd787abc55
1665057verapamil HCl 5 MG in 2 ML InjectionPSNe18cc04c-a808-4d92-9b66-762cd787abc55
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCDe18cc04c-a808-4d92-9b66-762cd787abc55
16650614 ML verapamil hydrochloride 2.5 MG/ML InjectionSCDe18cc04c-a808-4d92-9b66-762cd787abc55
1665061verapamil HCl 10 MG per 4 ML InjectionSYe18cc04c-a808-4d92-9b66-762cd787abc55
1665057verapamil HCl 5 MG per 2 ML InjectionSYe18cc04c-a808-4d92-9b66-762cd787abc55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65145-113-01651450113012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
65145-113-256514501132525 VIAL, SINGLE-DOSE in 1 CARTON (65145-113-25) / 2 mL in 1 VIAL, SINGLE-DOSE (65145-113-01) 2025-01-160000-00-00NoNoCurrent