FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
71335-1001
11-digit product format
713351001
Labeler code
71335
Product ID
71335-1001_ab8f75d5-8ef8-4d85-9430-82a1d1ecbca7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA018602
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-12-25
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1001-12024-01-30C16284748780-11030e365-50d2-111a-e063-dadaa90a10e2Diltiazem Hydrochloride Tablets
71335-1001-22024-01-30C16284748780-11030e365-50d2-111a-e063-dadaa90a10e2Diltiazem Hydrochloride Tablets
71335-1001-32024-01-30C16284748780-11030e365-50d2-111a-e063-dadaa90a10e2Diltiazem Hydrochloride Tablets
71335-1001-42024-01-30C16284748780-11030e365-50d2-111a-e063-dadaa90a10e2Diltiazem Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1001-1Diltiazem Hydrochloride30 in 1 BOTTLETABLET30100
71335-1001-2Diltiazem Hydrochloride90 in 1 BOTTLETABLET90100
71335-1001-3Diltiazem Hydrochloride60 in 1 BOTTLETABLET60100
71335-1001-4Diltiazem Hydrochloride100 in 1 BOTTLETABLET100100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1001DILTIAZEM HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]100Legacy NDC, 4 package rows20220212_13bfcfc6-deb9-439f-98ec-85a2b94b4a8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831103dilTIAZem hydrochloride 60 MG Oral TabletPSN13bfcfc6-deb9-439f-98ec-85a2b94b4a8a100
831103diltiazem hydrochloride 60 MG Oral TabletSCD13bfcfc6-deb9-439f-98ec-85a2b94b4a8a100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1001-17133510010130 TABLET in 1 BOTTLE (71335-1001-1) 30 tablet2022-02-110000-00-00NoNoCurrent
71335-1001-27133510010290 TABLET in 1 BOTTLE (71335-1001-2) 90 tablet2022-02-110000-00-00NoNoCurrent
71335-1001-37133510010360 TABLET in 1 BOTTLE (71335-1001-3) 60 tablet2022-02-110000-00-00NoNoCurrent
71335-1001-471335100104100 TABLET in 1 BOTTLE (71335-1001-4) 100 tablet2022-02-110000-00-00NoNoCurrent