FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
70710-1937
11-digit product format
707101937
Labeler code
70710
Product ID
70710-1937_9fc482f4-8fb1-47a3-a3ba-55f96fc92287
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA214215
Marketing category
ANDA
Marketing start
2023-10-17
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

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
70710-1937-1Verapamil Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION22
70710-1937-5Verapamil Hydrochloride5 in 1 CARTONINJECTION, SOLUTION52
70710-1937-7Verapamil Hydrochloride25 in 1 CARTONINJECTION, SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1937-1ML - Milliliter70710-1937e328f42b-4bcf-4583-86d1-63e1f683414512024-02-14
70710-1937-5ML - Milliliter70710-1937ce05f427-5409-4166-940f-9a4a5cc8b81812024-02-14
70710-1937-7ML - Milliliter70710-193760f24abc-17fb-4348-8a2c-048ed659bd6112024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1937VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION [ZYDUS PHARMACEUTICALS USA INC.]2Current NDC, 3 package rows20241208_a9a1a522-231b-41a1-95c6-0c75dbb62f47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665057verapamil HCl 5 MG in 2 ML InjectionPSNa9a1a522-231b-41a1-95c6-0c75dbb62f472
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCDa9a1a522-231b-41a1-95c6-0c75dbb62f472
1665057verapamil HCl 5 MG per 2 ML InjectionSYa9a1a522-231b-41a1-95c6-0c75dbb62f472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1937-1707101937012 mL in 1 VIAL2 mlHistorical
70710-1937-5707101937055 in 1 CARTONHistorical
70710-1937-77071019370725 CARTON in 1 CARTON (70710-1937-7) / 5 VIAL in 1 CARTON (70710-1937-5) / 2 mL in 1 VIAL (70710-1937-1) 25 carton2023-10-17NoNoCurrent