FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
71335-1585
11-digit product format
713351585
Labeler code
71335
Product ID
71335-1585_9308bc71-ce3f-429f-9926-d140481ad8ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA020401
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-08-20
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
Brand name suffix
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
71335-1585-1Diltiazem HydrochlorideEXTENDED RELEASE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE30103
71335-1585-2Diltiazem HydrochlorideEXTENDED RELEASE90 in 1 BOTTLECAPSULE, EXTENDED RELEASE90103
71335-1585-3Diltiazem HydrochlorideEXTENDED RELEASE18 in 1 BOTTLECAPSULE, EXTENDED RELEASE18103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1585-1EA - Each71335-158587815833-5063-4731-8436-48778a46333e12025-09-12
71335-1585-2EA - Each71335-15854eeed151-3b72-4f5e-b1cf-cdc7ff4b05b812025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1585DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 3 package rows20250123_c7c6a74e-5f73-4265-a0e0-8fd2cd26909e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNc7c6a74e-5f73-4265-a0e0-8fd2cd26909e103
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDc7c6a74e-5f73-4265-a0e0-8fd2cd26909e103
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYc7c6a74e-5f73-4265-a0e0-8fd2cd26909e103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1585-17133515850130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1585-1) 2022-02-110000-00-00NoNoCurrent
71335-1585-27133515850290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1585-2) 2022-02-110000-00-00NoNoCurrent
71335-1585-37133515850318 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-1585-3) 2022-02-110000-00-00NoNoCurrent