FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
63739-014
11-digit product format
637390014
Labeler code
63739
Product ID
63739-014_be23545a-cf46-fb38-e053-2995a90a4330
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, COATED, EXTENDED RELEASE
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA074984
Marketing category
ANDA
Marketing start
2015-10-01
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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
63739-014-102026-01-29C16284748780-1ab0e2407-2d72-f274-e053-dbdaa90a6471Diltiazem Hydrochloride Extended-Release Capsules, USP Rx Only
63739-014-102020-07-22C16284748780-1ab0e2407-2d72-f274-e053-dbdaa90a6471Diltiazem Hydrochloride Extended-Release Capsules, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63739-014-10Diltiazem HydrochlorideExtended-Release10 in 1 BOX, UNIT-DOSECAPSULE, COATED, EXTENDED RELEAS109
63739-014-10Diltiazem HydrochlorideExtended-Release10 in 1 BLISTER PACKCAPSULE, COATED, EXTENDED RELEAS109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-014-10EA - Each63739-014d6836a9a-f8fb-43b5-8c5a-bce8fb76fc3a12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-014DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [MCKESSON CORPORATION DBA SKY PACKAGING]9Legacy NDC, 2 package rows20240824_2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY2ec2afa8-f91a-46cd-ac4e-b8ffa59015ec9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-014-106373900141010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-014-10) > 10 CAPSULE, COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2017-07-132021-08-31NoNoCurrent