FDA.reportPublic FDA data

diltiazem hydrochloride

Product NDC
0615-8381
11-digit product format
006158381
Labeler code
0615
Product ID
0615-8381_72f92a1f-d8d6-494e-a8e9-875ca4bf4b50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA208783
Marketing category
ANDA
Marketing start
2019-06-14
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
240 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 HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830837, 830845, 830861

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
0615-8381-39diltiazem hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8381DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]4Current NDC, Legacy NDC, 1 package rows20240915_70f167a1-ec7f-4969-b446-166af3e52c05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN70f167a1-ec7f-4969-b446-166af3e52c054
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN70f167a1-ec7f-4969-b446-166af3e52c054
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN70f167a1-ec7f-4969-b446-166af3e52c054
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD70f167a1-ec7f-4969-b446-166af3e52c054
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD70f167a1-ec7f-4969-b446-166af3e52c054
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD70f167a1-ec7f-4969-b446-166af3e52c054
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY70f167a1-ec7f-4969-b446-166af3e52c054
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY70f167a1-ec7f-4969-b446-166af3e52c054
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY70f167a1-ec7f-4969-b446-166af3e52c054

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8381-390061583813930 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8381-39) 2021-02-090000-00-00NoNoCurrent