FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
71335-1223
11-digit product format
713351223
Labeler code
71335
Product ID
71335-1223_101f9485-011d-4f61-acd2-1cae23cdd2f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074984
Marketing category
ANDA
Marketing start
2015-10-01
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
120 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 HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830861

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
71335-1223-1Diltiazem HydrochlorideExtended-Release30 in 1 BOTTLECAPSULE, COATED, EXTENDED RELEAS3012
71335-1223-2Diltiazem HydrochlorideExtended-Release90 in 1 BOTTLECAPSULE, COATED, EXTENDED RELEAS9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1223-1EA - Each71335-12238813b6df-1b9f-4654-8ab7-c71eb8e2648512020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1223DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]12Current NDC, Legacy NDC, 2 package rows20240407_74232d69-1a8c-449d-8e8e-85488e6cc8f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN74232d69-1a8c-449d-8e8e-85488e6cc8f812
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD74232d69-1a8c-449d-8e8e-85488e6cc8f812
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY74232d69-1a8c-449d-8e8e-85488e6cc8f812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1223-17133512230130 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1223-1) 2019-05-090000-00-00NoNoCurrent
71335-1223-27133512230290 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1223-2) 2023-12-150000-00-00NoNoCurrent