FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
65219-384
11-digit product format
652190384
Labeler code
65219
Product ID
65219-384_f3bdbd6b-0e61-43d3-8016-3edd69bedd38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
FRESENIUS KABI USA, LLC
Application
ANDA216471
Marketing category
ANDA
Marketing start
2024-11-25
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

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
65219-384-01Verapamil Hydrochloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION21
65219-384-02Verapamil Hydrochloride25 in 1 CARTONINJECTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-384-01ML - Milliliter65219-384ec90d1e3-2b57-42b3-bde5-8c799916ec0d12024-12-10
65219-384-02ML - Milliliter65219-384d97618e1-4a40-4b50-afce-163e9373393812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-384VERAPAMIL HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC ]1Current NDC, 2 package rows20241126_38ca9270-5538-467a-a3e9-c27968f3aafe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665057verapamil HCl 5 MG in 2 ML InjectionPSN38ca9270-5538-467a-a3e9-c27968f3aafe1
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD38ca9270-5538-467a-a3e9-c27968f3aafe1
1665057verapamil HCl 5 MG per 2 ML InjectionSY38ca9270-5538-467a-a3e9-c27968f3aafe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-384-01652190384012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
65219-384-026521903840225 VIAL, SINGLE-DOSE in 1 CARTON (65219-384-02) / 2 mL in 1 VIAL, SINGLE-DOSE (65219-384-01) 2024-11-25NoNoCurrent