FDA.reportPublic FDA data

Cartia

Product NDC
50090-3124
11-digit product format
500903124
Labeler code
50090
Product ID
50090-3124_bf63b3d6-5124-435d-88aa-c5091802b6c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA074752
Marketing category
ANDA
Marketing start
1998-07-09
Marketing end
0000-00-00
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
180 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
50090-3124-02024-01-30C16284748780-11030e365-015d-111a-e063-dadaa90a10e2CARTIA XT ® brand of DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP (ONCE-A-DAY DOSAGE) Rx only
50090-3124-12024-01-30C16284748780-11030e365-015d-111a-e063-dadaa90a10e2CARTIA XT ® brand of DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP (ONCE-A-DAY DOSAGE) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3124-0CartiaXT30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010
50090-3124-1CartiaXT90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3124-0EA - Each50090-31244caf09ac-5ec0-460b-b067-7cc30d2c882012019-05-02
50090-3124-1EA - Each50090-3124cf42d1ea-efff-43b0-82a4-3c799cfb741b12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3124CARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]10Legacy NDC, 2 package rows20220208_795f516a-9fda-48ef-84a5-4e2e4ff7a756.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831226Cartia XT 120 MG 24HR Extended Release Oral Capsule, Once-A-DayPSN795f516a-9fda-48ef-84a5-4e2e4ff7a75610
831255Cartia XT 180 MG 24HR Extended Release Oral Capsule, Once-A-DayPSN795f516a-9fda-48ef-84a5-4e2e4ff7a75610
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN795f516a-9fda-48ef-84a5-4e2e4ff7a75610
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN795f516a-9fda-48ef-84a5-4e2e4ff7a75610
83122624 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule [Cartia]SBD795f516a-9fda-48ef-84a5-4e2e4ff7a75610
83125524 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule [Cartia]SBD795f516a-9fda-48ef-84a5-4e2e4ff7a75610
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD795f516a-9fda-48ef-84a5-4e2e4ff7a75610
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD795f516a-9fda-48ef-84a5-4e2e4ff7a75610
83122624 HR Cartia 120 MG Extended Release Oral CapsuleSY795f516a-9fda-48ef-84a5-4e2e4ff7a75610
83125524 HR Cartia 180 MG Extended Release Oral CapsuleSY795f516a-9fda-48ef-84a5-4e2e4ff7a75610
831226Cartia 120 MG 24 HR Extended Release Oral CapsuleSY795f516a-9fda-48ef-84a5-4e2e4ff7a75610
831255Cartia 180 MG 24 HR Extended Release Oral CapsuleSY795f516a-9fda-48ef-84a5-4e2e4ff7a75610
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY795f516a-9fda-48ef-84a5-4e2e4ff7a75610
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY795f516a-9fda-48ef-84a5-4e2e4ff7a75610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3124-05009031240030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-3124-0) 2017-08-210000-00-00NoNoCurrent
50090-3124-15009031240190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-3124-1) 2022-02-040000-00-00NoNoCurrent