FDA.reportPublic FDA data

diltiazem hydrochloride

Product NDC
43353-903
11-digit product format
433530903
Labeler code
43353
Product ID
43353-903_5daab746-e686-48fc-a47d-ba12ec36b88f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA020401
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-09-25
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
360 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
43353-903-792020-01-31C16284748780-19d75b9d0-8aa9-f424-e053-dadaa90a57ceDiltiazem hydrochloride Extended Release Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-903-79diltiazem hydrochloride2160 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE21601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-903DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20140529_bf56b78c-9ace-4404-9147-707d61379237.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSNbf56b78c-9ace-4404-9147-707d613792371
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSNbf56b78c-9ace-4404-9147-707d613792371
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNbf56b78c-9ace-4404-9147-707d613792371
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSNbf56b78c-9ace-4404-9147-707d613792371
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSNbf56b78c-9ace-4404-9147-707d613792371
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDbf56b78c-9ace-4404-9147-707d613792371
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCDbf56b78c-9ace-4404-9147-707d613792371
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDbf56b78c-9ace-4404-9147-707d613792371
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCDbf56b78c-9ace-4404-9147-707d613792371
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCDbf56b78c-9ace-4404-9147-707d613792371
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSYbf56b78c-9ace-4404-9147-707d613792371
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSYbf56b78c-9ace-4404-9147-707d613792371
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYbf56b78c-9ace-4404-9147-707d613792371
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYbf56b78c-9ace-4404-9147-707d613792371
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSYbf56b78c-9ace-4404-9147-707d613792371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-903-79433530903792160 in 1 BOTTLE, PLASTICHistorical