FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
51754-0203
11-digit product format
517540203
Labeler code
51754
Product ID
51754-0203_d053ac54-7922-4e79-a5a2-62eb3c2c3f4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
EXELA PHARMA SCIENCES, LLC
Application
NDA018925
Marketing category
NDA
Marketing start
2016-04-22
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
51754-0203-2Verapamil Hydrochloride5 in 1 CARTONINJECTION56
51754-0203-2Verapamil Hydrochloride2 mL in 1 VIALINJECTION26
51754-0203-4Verapamil Hydrochloride2 mL in 1 VIALINJECTION26
51754-0203-4Verapamil Hydrochloride25 in 1 CARTONINJECTION256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-0203VERAPAMIL HYDROCHLORIDE INJECTION [EXELA PHARMA SCIENCES, LLC]6Current NDC, Legacy NDC, 4 package rows20210916_eff5e83b-f819-4a5b-9746-12bce328d7a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665061verapamil HCl 10 MG in 4 ML InjectionPSNeff5e83b-f819-4a5b-9746-12bce328d7a76
1665057verapamil HCl 5 MG in 2 ML InjectionPSNeff5e83b-f819-4a5b-9746-12bce328d7a76
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCDeff5e83b-f819-4a5b-9746-12bce328d7a76
16650614 ML verapamil hydrochloride 2.5 MG/ML InjectionSCDeff5e83b-f819-4a5b-9746-12bce328d7a76
1665061verapamil HCl 10 MG per 4 ML InjectionSYeff5e83b-f819-4a5b-9746-12bce328d7a76
1665057verapamil HCl 5 MG per 2 ML InjectionSYeff5e83b-f819-4a5b-9746-12bce328d7a76
1665057verapamil HCl 5 MG in 2 ML InjectionPSN6685248d-908e-cd07-e053-2a91aa0ac7183
1665057verapamil HCl 5 MG in 2 ML InjectionPSN9a4f12ec-fe1c-a1b9-e053-2a95a90ac8e43
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD6685248d-908e-cd07-e053-2a91aa0ac7183
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD9a4f12ec-fe1c-a1b9-e053-2a95a90ac8e43
1665057verapamil HCl 5 MG per 2 ML InjectionSY6685248d-908e-cd07-e053-2a91aa0ac7183
1665057verapamil HCl 5 MG per 2 ML InjectionSY9a4f12ec-fe1c-a1b9-e053-2a95a90ac8e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51754-0203-2517540203025 VIAL in 1 CARTON (51754-0203-2) / 2 mL in 1 VIAL5 vial2016-04-220000-00-00NoNoCurrent
51754-0203-45175402030425 VIAL in 1 CARTON (51754-0203-4) / 2 mL in 1 VIAL25 vial2016-12-090000-00-00NoNoCurrent