FDA.reportPublic FDA data

diltiazem hydrochloride

Product NDC
71335-3091
11-digit product format
713353091
Labeler code
71335
Product ID
71335-3091_8cef16b7-12fc-4ff4-8379-ec6c9a4b2a19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
diltiazem hydrochloride
Listing expiration
2027-12-31

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
71335-3091-1diltiazem hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
71335-3091-2diltiazem hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901
71335-3091-3diltiazem hydrochloride18 in 1 BOTTLECAPSULE, EXTENDED RELEASE181

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNa469b24a-fbec-4a2d-8b4c-b62c2b2c66f61
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDa469b24a-fbec-4a2d-8b4c-b62c2b2c66f61
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYa469b24a-fbec-4a2d-8b4c-b62c2b2c66f61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3091-17133530910130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-3091-1) 2026-02-17NoNoHistorical
71335-3091-27133530910290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-3091-2) 2026-02-17NoNoHistorical
71335-3091-37133530910318 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-3091-3) 2026-02-17NoNoHistorical