FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
70121-1585
11-digit product format
701211585
Labeler code
70121
Product ID
70121-1585_87cb3647-64f7-4552-8d42-c4090492991a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA210994
Marketing category
ANDA
Marketing start
2018-07-17
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
70121-1585-1Verapamil Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION27
70121-1585-5Verapamil Hydrochloride25 in 1 CARTONINJECTION, SOLUTION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1585-1ML - Milliliter70121-1585d7b00b5e-f0a1-45a9-a316-d40fd1be37bd12019-04-11
70121-1585-5ML - Milliliter70121-158598cfa859-409b-4a36-af90-2c77935cd7be12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1585VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC]7Current NDC, Legacy NDC, 2 package rows20240711_9055ed6b-f466-4f38-a9d9-f22e9ac97ad4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665061verapamil HCl 10 MG in 4 ML InjectionPSN9055ed6b-f466-4f38-a9d9-f22e9ac97ad47
1665057verapamil HCl 5 MG in 2 ML InjectionPSN9055ed6b-f466-4f38-a9d9-f22e9ac97ad47
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD9055ed6b-f466-4f38-a9d9-f22e9ac97ad47
16650614 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD9055ed6b-f466-4f38-a9d9-f22e9ac97ad47
1665061verapamil HCl 10 MG per 4 ML InjectionSY9055ed6b-f466-4f38-a9d9-f22e9ac97ad47
1665057verapamil HCl 5 MG per 2 ML InjectionSY9055ed6b-f466-4f38-a9d9-f22e9ac97ad47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1585-1701211585012 mL in 1 VIAL2 mlHistorical
70121-1585-57012115850525 VIAL in 1 CARTON (70121-1585-5) / 2 mL in 1 VIAL (70121-1585-1) 25 vial2018-07-170000-00-00NoNoCurrent