FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
72485-108
11-digit product format
724850108
Labeler code
72485
Product ID
72485-108_065dae38-a47b-4d8c-b067-d45ebd1eee99
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
5 mg/2mL
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 HYDROCHLORIDE5 mg/2mL

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
72485-108-01Verapamil Hydrochloride2 mL in 1 VIALINJECTION21
72485-108-05Verapamil Hydrochloride5 in 1 CARTONINJECTION51
72485-108-25Verapamil Hydrochloride25 in 1 CARTONINJECTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-108-01ML - Milliliter72485-108880a0015-6732-41c2-8ed4-44ce1d6226f012020-02-13
72485-108-05ML - Milliliter72485-1081396d9b3-1a46-4f2b-aecc-a285e47ae33a12020-02-13
72485-108-25ML - Milliliter72485-1085fda7383-1a3c-4785-affa-fb530480d0ed12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-108VERAPAMIL HYDROCHLORIDE INJECTION [ARMAS PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 3 package rows20200111_51597adb-bfb1-4611-b577-8989724fc3a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665057verapamil HCl 5 MG in 2 ML InjectionPSN9f19a5b4-286c-2c3f-e053-2a95a90a51df2
1665057verapamil HCl 5 MG in 2 ML InjectionPSNa2a4b816-417c-4a37-e053-2995a90a02202
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD9f19a5b4-286c-2c3f-e053-2a95a90a51df2
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCDa2a4b816-417c-4a37-e053-2995a90a02202
1665057verapamil HCl 5 MG per 2 ML InjectionSY9f19a5b4-286c-2c3f-e053-2a95a90a51df2
1665057verapamil HCl 5 MG per 2 ML InjectionSYa2a4b816-417c-4a37-e053-2995a90a02202
1665057verapamil HCl 5 MG in 2 ML InjectionPSN51597adb-bfb1-4611-b577-8989724fc3a41
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD51597adb-bfb1-4611-b577-8989724fc3a41
1665057verapamil HCl 5 MG per 2 ML InjectionSY51597adb-bfb1-4611-b577-8989724fc3a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72485-108-01724850108012 mL in 1 VIAL2 mlHistorical
72485-108-05724850108055 VIAL in 1 CARTON (72485-108-05) / 2 mL in 1 VIAL (72485-108-01) 5 vial2020-01-010000-00-00NoNoCurrent
72485-108-257248501082525 VIAL in 1 CARTON (72485-108-25) / 2 mL in 1 VIAL (72485-108-01) 25 vial2020-01-010000-00-00NoNoCurrent