FDA.reportPublic FDA data

VERAPAMIL HYDROCHLORIDE

Product NDC
51662-1686
11-digit product format
516621686
Labeler code
51662
Product ID
51662-1686_51191e37-c228-217f-e063-6394a90a467a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VERAPAMIL HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA211015
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VERAPAMIL HYDROCHLORIDE
Listing expiration
2027-12-31

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
51662-1686-1VERAPAMIL HYDROCHLORIDE2 mL in 1 VIALINJECTION, SOLUTION22
51662-1686-2VERAPAMIL HYDROCHLORIDE1 in 1 POUCHINJECTION, SOLUTION12
51662-1686-3VERAPAMIL HYDROCHLORIDE25 in 1 BOXINJECTION, SOLUTION252

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665057verapamil HCl 5 MG in 2 ML InjectionPSN4dcc46d8-76b0-fbd4-e063-6294a90ad9e62
16650572 ML verapamil hydrochloride 2.5 MG/ML InjectionSCD4dcc46d8-76b0-fbd4-e063-6294a90ad9e62
1665057verapamil HCl 5 MG per 2 ML InjectionSY4dcc46d8-76b0-fbd4-e063-6294a90ad9e62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1686-1516621686012 mL in 1 VIAL2 mlHistorical
51662-1686-2516621686021 in 1 POUCHHistorical
51662-1686-35166216860325 POUCH in 1 BOX (51662-1686-3) / 1 VIAL in 1 POUCH (51662-1686-2) / 2 mL in 1 VIAL (51662-1686-1) 25 pouch2018-06-18NoNoCurrent