FDA.reportPublic FDA data

DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE

Product NDC
72189-248
11-digit product format
721890248
Labeler code
72189
Product ID
72189-248_2c2871ee-eb23-78d5-e063-6294a90a2de9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
direct rx
Application
NDA020401
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-07-23
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 EXTENDED RELEASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830837

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
72189-248-90DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE90 in 1 BOTTLECAPSULE, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-248DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE CAPSULE, EXTENDED RELEASE [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20250121_c7cf9276-4b4c-10b2-e053-2995a90a3738.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNc7cf9276-4b4c-10b2-e053-2995a90a37382
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDc7cf9276-4b4c-10b2-e053-2995a90a37382
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYc7cf9276-4b4c-10b2-e053-2995a90a37382

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-248-907218902489090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-248-90) 2021-07-230000-00-00NoNoCurrent