FDA.reportPublic FDA data

Nicardipine Hydrochloride

Product NDC
70069-875
11-digit product format
700690875
Labeler code
70069
Product ID
70069-875_035cb7ef-c5d5-4752-8d43-61b8e8420330
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nicardipine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA220243
Marketing category
ANDA
Marketing start
2026-04-20
Substance
NICARDIPINE HYDROCHLORIDE
Active strength
.1 mg/mL
Pharmacologic classes
Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicardipine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICARDIPINE HYDROCHLORIDE.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK5BC5011K3
Rxcui858599, 858603

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
31746078-c5c3-4387-a2ed-bd3c8b244c53Product name220250325
037c6bd8-1c81-7b8c-8280-c83d993a1f03Product name220250203
c9eb0343-053f-7f78-730f-1be02ab91c6cProduct name520250130

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-875-01Nicardipine Hydrochloride200 mL in 1 BAGINJECTION2002
70069-875-01Nicardipine Hydrochloride1 in 1 POUCHINJECTION12
70069-875-10Nicardipine Hydrochloride10 in 1 CASEINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-875-01ML - Milliliter70069-875501832ba-a08e-4f73-a746-559ee030ef9712026-05-22
70069-875-10ML - Milliliter70069-875755aa2f0-a16f-4d83-a5b6-d934e6aa5ece12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858599niCARdipine HCl 20 MG in 200 ML InjectionPSNf8b49f59-7a54-425d-9eca-dfa4022a08d12
858603niCARdipine HCl 40 MG in 200 ML InjectionPSNf8b49f59-7a54-425d-9eca-dfa4022a08d12
858599200 ML nicardipine hydrochloride 0.1 MG/ML InjectionSCDf8b49f59-7a54-425d-9eca-dfa4022a08d12
858603200 ML nicardipine hydrochloride 0.2 MG/ML InjectionSCDf8b49f59-7a54-425d-9eca-dfa4022a08d12
858599nicardipine hydrochloride 20 MG per 200 ML InjectionSYf8b49f59-7a54-425d-9eca-dfa4022a08d12
858603nicardipine hydrochloride 40 MG per 200 ML InjectionSYf8b49f59-7a54-425d-9eca-dfa4022a08d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-875-0170069087501200 mL in 1 BAG200 mlHistorical
70069-875-107006908751010 POUCH in 1 CASE (70069-875-10) / 1 BAG in 1 POUCH (70069-875-01) / 200 mL in 1 BAG10 pouch2026-04-20NoNoHistorical