FDA.reportPublic FDA data

Diltiazem Hydrochloride Extended-Release

Product NDC
73190-012
11-digit product format
731900012
Labeler code
73190
Product ID
73190-012_31e63aa7-6748-ffcf-e063-6294a90a5590
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA215775
Marketing category
ANDA
Marketing start
2025-04-03
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
90 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 HYDROCHLORIDE90 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830865, 830869, 830872

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
73190-012-01Diltiazem Hydrochloride Extended-Release100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73190-012-01EA - Each73190-0121fbd9c5e-48d2-4522-8567-bcd0d2791d5612025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73190-012DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [AVKARE]1Current NDC, 1 package rows20250406_31e63a95-9e62-01c8-e063-6294a90af0e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830872dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral CapsulePSN31e63a95-9e62-01c8-e063-6294a90af0e11
830865dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral CapsulePSN31e63a95-9e62-01c8-e063-6294a90af0e11
830869dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral CapsulePSN31e63a95-9e62-01c8-e063-6294a90af0e11
83087212 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD31e63a95-9e62-01c8-e063-6294a90af0e11
83086512 HR diltiazem hydrochloride 60 MG Extended Release Oral CapsuleSCD31e63a95-9e62-01c8-e063-6294a90af0e11
83086912 HR diltiazem hydrochloride 90 MG Extended Release Oral CapsuleSCD31e63a95-9e62-01c8-e063-6294a90af0e11
830872diltiazem hydrochloride 120 MG 12 HR Extended Release Oral CapsuleSY31e63a95-9e62-01c8-e063-6294a90af0e11
830865diltiazem hydrochloride 60 MG 12 HR Extended Release Oral CapsuleSY31e63a95-9e62-01c8-e063-6294a90af0e11
830869diltiazem hydrochloride 90 MG 12 HR Extended Release Oral CapsuleSY31e63a95-9e62-01c8-e063-6294a90af0e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73190-012-0173190001201100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-012-01) 2025-04-03NoNoCurrent