FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
0615-8033
11-digit product format
006158033
Labeler code
0615
Product ID
0615-8033_f396d205-71ac-4e1a-b989-a6a2c2da9677
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA074185
Marketing category
ANDA
Marketing start
1995-12-22
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 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
Diltiazem Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui831103, 833217

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8033-39Diltiazem Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8033DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]8Current NDC, Legacy NDC, 1 package rows20240915_74620be9-5120-491a-a171-e50612c06541.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833217dilTIAZem hydrochloride 30 MG Oral TabletPSN74620be9-5120-491a-a171-e50612c065418
831103dilTIAZem hydrochloride 60 MG Oral TabletPSN74620be9-5120-491a-a171-e50612c065418
833217diltiazem hydrochloride 30 MG Oral TabletSCD74620be9-5120-491a-a171-e50612c065418
831103diltiazem hydrochloride 60 MG Oral TabletSCD74620be9-5120-491a-a171-e50612c065418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8033-390061580333930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8033-39) 2016-05-170000-00-00NoNoCurrent