FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
70069-273
11-digit product format
700690273
Labeler code
70069
Product ID
70069-273_6d4f205d-626c-4285-ba7b-c0ca536c7875
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA211035
Marketing category
ANDA
Marketing start
2018-06-18
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
70069-273-01Verapamil Hydrochloride2 mL in 1 AMPULEINJECTION, SOLUTION212
70069-273-05Verapamil Hydrochloride5 in 1 TRAYINJECTION, SOLUTION512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-273-01ML - Milliliter70069-27381138add-6fa8-4e90-9aff-edbbec8293d012022-11-07
70069-273-05ML - Milliliter70069-27306446904-23a7-4705-b6a7-51798043269512022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-273VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC]12Current NDC, Legacy NDC, 2 package rows20230317_50131bbc-ad43-4708-946f-e4000828137c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665061verapamil HCl 10 MG in 4 ML InjectionPSN50131bbc-ad43-4708-946f-e4000828137c12
1665057verapamil HCl 5 MG in 2 ML InjectionPSN50131bbc-ad43-4708-946f-e4000828137c12
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD50131bbc-ad43-4708-946f-e4000828137c12
16650614 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD50131bbc-ad43-4708-946f-e4000828137c12
1665061verapamil HCl 10 MG per 4 ML InjectionSY50131bbc-ad43-4708-946f-e4000828137c12
1665057verapamil HCl 5 MG per 2 ML InjectionSY50131bbc-ad43-4708-946f-e4000828137c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70069-273-01700690273012 mL in 1 AMPULE2 mlHistorical
70069-273-05700690273055 AMPULE in 1 TRAY (70069-273-05) / 2 mL in 1 AMPULE (70069-273-01) 5 ampule2018-06-180000-00-00NoNoCurrent