FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
24658-174
11-digit product format
246580174
Labeler code
24658
Product ID
24658-174_c20d158b-7eb9-4b92-b76b-cd6e036abd22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
PuraCap Laboratories LLC
Application
NDA020401
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-11-01
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
2020-12-31
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
24658-174-302021-01-29C16284748780-1ba0f9c33-2a43-a910-e053-dadaa90a0b85Diltiazem Hydrochloride Extended-Release Capsules
24658-174-902021-01-29C16284748780-1ba0f9c33-2a43-a910-e053-dadaa90a0b85Diltiazem Hydrochloride Extended-Release Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24658-174-30Diltiazem Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE304
24658-174-90Diltiazem Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-174-30EA - Each24658-174d55c5ad5-b5c7-4db5-b4dc-5f02907c681512017-03-06
24658-174-90EA - Each24658-1747b92ff9a-d279-43b0-95eb-288e2c59c6b412017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-174DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PURACAP LABORATORIES LLC]4Legacy NDC, 2 package rows20191119_9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSN9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSN9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
831359dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral CapsulePSN9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCD9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCD9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
83135924 HR diltiazem hydrochloride 420 MG Extended Release Oral CapsuleSCD9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSY9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSY9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14
831359diltiazem hydrochloride 420 MG 24 HR Extended Release Oral CapsuleSY9be536b1-1ba6-42d2-9d5a-2b8a1c83c0b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
24658-174-302465801743030 in 1 BOTTLEHistorical
24658-174-902465801749090 in 1 BOTTLEHistorical