FDA.reportPublic FDA data

Cartia

Product NDC
63629-7896
11-digit product format
636297896
Labeler code
63629
Product ID
63629-7896_b40726ef-bcfa-4250-9c7c-cf8473c61f67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074752
Marketing category
ANDA
Marketing start
1998-07-09
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
120 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cartia
Brand name suffix
XT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830861, 831226

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
63629-7896-12025-06-02C16284748780-11030e365-3e2a-111a-e063-dadaa90a10e2CARTIA XT ® brand of DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP (ONCE-A-DAY DOSAGE) Rx only
63629-7896-22025-06-02C16284748780-11030e365-3e2a-111a-e063-dadaa90a10e2CARTIA XT ® brand of DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP (ONCE-A-DAY DOSAGE) Rx only
63629-7896-12024-01-30C16284748780-11030e365-3e2a-111a-e063-dadaa90a10e2CARTIA XT ® brand of DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP (ONCE-A-DAY DOSAGE) Rx only
63629-7896-22024-01-30C16284748780-11030e365-3e2a-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
63629-7896-1CartiaXT30 in 1 BOTTLECAPSULE, EXTENDED RELEASE306
63629-7896-2CartiaXT90 in 1 BOTTLECAPSULE, EXTENDED RELEASE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7896CARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 2 package rows20220118_de671934-25a8-4df6-b7a1-97e0337e9e2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831226Cartia XT 120 MG 24HR Extended Release Oral Capsule, Once-A-DayPSNde671934-25a8-4df6-b7a1-97e0337e9e2b6
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSNde671934-25a8-4df6-b7a1-97e0337e9e2b6
83122624 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule [Cartia]SBDde671934-25a8-4df6-b7a1-97e0337e9e2b6
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDde671934-25a8-4df6-b7a1-97e0337e9e2b6
83122624 HR Cartia 120 MG Extended Release Oral CapsuleSYde671934-25a8-4df6-b7a1-97e0337e9e2b6
831226Cartia 120 MG 24 HR Extended Release Oral CapsuleSYde671934-25a8-4df6-b7a1-97e0337e9e2b6
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSYde671934-25a8-4df6-b7a1-97e0337e9e2b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7896-16362978960130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-7896-1) 2019-01-150000-00-00NoNoCurrent
63629-7896-26362978960290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-7896-2) 2021-12-230000-00-00NoNoCurrent