FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
0641-9218
11-digit product format
006419218
Labeler code
0641
Product ID
0641-9218_82ec8594-72c0-4636-9b36-74fe724f750e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078538
Marketing category
ANDA
Marketing start
2008-12-17
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 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
Diltiazem Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui1791229, 1791232, 1791233

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
61ebbccf-eedf-453b-940e-dba67b7a5fefProduct name420260107
a8d6eaa3-afcc-47e5-be12-0c9251fc8740Product name120251124
f6700316-a6ba-5e59-3413-8ede05ae58b9Product name720250625
8615f7a1-1e8f-8281-8601-d7a637926d1fProduct name420250522
3a9daa2f-bcd1-13de-a1b4-6172caa7f308Product name220240419
f7129636-cba8-86c2-8bfb-9e2e2a9c7628Product name220240314
378290be-e30f-0e68-1201-165e93c337e8Product name320231212
c733b56e-b0b5-4495-9857-0256a8242279Product name120220520
f4df4721-60d9-7fd2-a665-5c3c9f55af81Product name220171003
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-9218-01Diltiazem Hydrochloride10 mL in 1 VIALINJECTION106
0641-9218-10Diltiazem Hydrochloride10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-9218-01ML - Milliliter0641-92188cb67b96-ef50-4b97-9a88-be1866d4dae812016-09-02
0641-9218-10ML - Milliliter0641-921843f31a1e-52ee-444d-ae8a-1e20e8fea5e112016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-9218DILTIAZEM HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20240410_734beeef-3968-4137-af2c-276e8a9317df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791233dilTIAZem hydrochloride 125 MG in 25 mL InjectionPSN734beeef-3968-4137-af2c-276e8a9317df6
1791229dilTIAZem hydrochloride 25 MG in 5 mL InjectionPSN734beeef-3968-4137-af2c-276e8a9317df6
1791232dilTIAZem hydrochloride 50 MG in 10 mL InjectionPSN734beeef-3968-4137-af2c-276e8a9317df6
179123210 ML diltiazem hydrochloride 5 MG/ML InjectionSCD734beeef-3968-4137-af2c-276e8a9317df6
179123325 ML diltiazem hydrochloride 5 MG/ML InjectionSCD734beeef-3968-4137-af2c-276e8a9317df6
17912295 ML diltiazem hydrochloride 5 MG/ML InjectionSCD734beeef-3968-4137-af2c-276e8a9317df6
1791233diltiazem hydrochloride 125 MG per 25 ML InjectionSY734beeef-3968-4137-af2c-276e8a9317df6
1791229diltiazem hydrochloride 25 MG per 5 ML InjectionSY734beeef-3968-4137-af2c-276e8a9317df6
1791232diltiazem hydrochloride 50 MG per 10 ML InjectionSY734beeef-3968-4137-af2c-276e8a9317df6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-9218-010064192180110 mL in 1 VIAL10 mlHistorical
0641-9218-100064192181010 VIAL in 1 CARTON (0641-9218-10) / 10 mL in 1 VIAL (0641-9218-01) 10 vial2008-12-170000-00-00NoNoCurrent