FDA.reportPublic FDA data

Verapamil Hydrochloride

Product NDC
42571-313
11-digit product format
425710313
Labeler code
42571
Product ID
42571-313_874186a5-c314-9d21-e053-2995a90ae376
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Verapamil Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Micro Labs Limited
Application
ANDA211370
Marketing category
ANDA
Marketing start
2019-03-04
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
42571-313-75Verapamil Hydrochloride1 in 1 CARTONINJECTION15
42571-313-75Verapamil Hydrochloride2 mL in 1 VIALINJECTION25
42571-313-86Verapamil Hydrochloride1 in 1 CARTONINJECTION15
42571-313-86Verapamil Hydrochloride4 mL in 1 VIALINJECTION45
42571-313-87Verapamil Hydrochloride25 in 1 CARTONINJECTION255
42571-313-87Verapamil Hydrochloride2 mL in 1 VIALINJECTION25
42571-313-96Verapamil Hydrochloride4 mL in 1 VIALINJECTION45
42571-313-96Verapamil Hydrochloride5 in 1 CARTONINJECTION55
42571-313-97Verapamil Hydrochloride5 in 1 CARTONINJECTION55
42571-313-97Verapamil Hydrochloride2 mL in 1 VIALINJECTION25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-313-86ML - Milliliter42571-3138f466252-7765-478e-8a36-b8ed6b3cd04d12019-08-06
42571-313-87ML - Milliliter42571-313149c3c6d-0b39-495e-a54f-4e2a5a3aed0c12019-07-02
42571-313-96ML - Milliliter42571-313ccc76b0a-10fe-424c-8444-9fca3bdbc06e12019-07-02
42571-313-97ML - Milliliter42571-31394222e2a-8a57-4d58-a82f-18764b835cb812019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-313VERAPAMIL HYDROCHLORIDE INJECTION [MICRO LABS LIMITED]5Current NDC, Legacy NDC, 10 package rows20190424_9c89764e-ff07-4077-a40f-91eb1c179af2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665061verapamil HCl 10 MG in 4 ML InjectionPSN9c89764e-ff07-4077-a40f-91eb1c179af25
1665057verapamil HCl 5 MG in 2 ML InjectionPSN9c89764e-ff07-4077-a40f-91eb1c179af25
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD9c89764e-ff07-4077-a40f-91eb1c179af25
16650614 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD9c89764e-ff07-4077-a40f-91eb1c179af25
1665061verapamil HCl 10 MG per 4 ML InjectionSY9c89764e-ff07-4077-a40f-91eb1c179af25
1665057verapamil HCl 5 MG per 2 ML InjectionSY9c89764e-ff07-4077-a40f-91eb1c179af25
1665057verapamil HCl 5 MG in 2 ML InjectionPSN9e04440f-4cee-990b-e053-2995a90a09e12
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD9e04440f-4cee-990b-e053-2995a90a09e12
1665057verapamil HCl 5 MG per 2 ML InjectionSY9e04440f-4cee-990b-e053-2995a90a09e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-313-75425710313751 VIAL in 1 CARTON (42571-313-75) / 2 mL in 1 VIAL1 vial2019-03-040000-00-00NoNoCurrent
42571-313-86425710313861 VIAL in 1 CARTON (42571-313-86) / 4 mL in 1 VIAL1 vial2019-03-040000-00-00NoNoCurrent
42571-313-874257103138725 VIAL in 1 CARTON (42571-313-87) / 2 mL in 1 VIAL25 vial2019-04-240000-00-00NoNoCurrent
42571-313-96425710313965 VIAL in 1 CARTON (42571-313-96) / 4 mL in 1 VIAL5 vial2019-04-240000-00-00NoNoCurrent
42571-313-97425710313975 VIAL in 1 CARTON (42571-313-97) / 2 mL in 1 VIAL5 vial2019-04-240000-00-00NoNoCurrent