Diltiazem Hydrochloride

Product NDC
50090-1576
11-digit product format
500901576
Labeler code
50090
Product ID
50090-1576_da54d6cd-6dfb-42a1-9cb8-223c988430c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075116
Marketing category
ANDA
Marketing start
1999-12-28
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
E
Listing certified through
2018-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1576-0Diltiazem Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
50090-1576-1Diltiazem Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1576DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20171221_3fd55e8d-3b85-4e3b-b2f0-e540075638c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN3fd55e8d-3b85-4e3b-b2f0-e540075638c63
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD3fd55e8d-3b85-4e3b-b2f0-e540075638c63
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY3fd55e8d-3b85-4e3b-b2f0-e540075638c63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-1576-05009015760030 in 1 BOTTLEHistorical
50090-1576-15009015760190 in 1 BOTTLEHistorical