FDA.reportPublic FDA data

Cartia

Product NDC
62037-597
11-digit product format
620370597
Labeler code
62037
Product ID
62037-597_cf6e0dbd-317f-430e-909d-5dd9e5a59f6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cartia
Brand name suffix
XT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830801, 830837, 830845, 830861, 831226, 831255, 831309, 831338

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62037-597-05CartiaXT500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50021
62037-597-90CartiaXT90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62037-597-05EA - Each62037-597cffb9a6f-e412-42d8-834a-adaf409c167b12012-07-24
62037-597-90EA - Each62037-597814e20f5-4824-499a-9786-93bc3177d89512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DILTIAZEM HYDROCHLORIDEACTIVE INGREDIENTOLH94387TECARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
DILTIAZEMACTIVE MOIETYEE92BBP03HCARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZCARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
AMMONIO METHACRYLATE COPOLYMER TYPE BINACTIVE INGREDIENT161H3B14U2CARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
ETHYLCELLULOSE (10 MPA.S)INACTIVE INGREDIENT3DYK7UYZ62CARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
GELATININACTIVE INGREDIENT2G86QN327LCARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577CARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
SUCROSEINACTIVE INGREDIENTC151H8M554CARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UCARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62037-597CARTIA XT (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]18Current NDC, Legacy NDC, 2 package rows20250514_2dc2b889-8443-4f7f-83be-86c68e179804.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831226Cartia XT 120 MG 24HR Extended Release Oral Capsule, Once-A-DayPSN2dc2b889-8443-4f7f-83be-86c68e17980421
831255Cartia XT 180 MG 24HR Extended Release Oral Capsule, Once-A-DayPSN2dc2b889-8443-4f7f-83be-86c68e17980421
831309Cartia XT 240 MG 24HR Extended Release Oral Capsule, Once-A-DayPSN2dc2b889-8443-4f7f-83be-86c68e17980421
831338Cartia XT 300 MG 24HR Extended Release Oral Capsule, Once-A-DayPSN2dc2b889-8443-4f7f-83be-86c68e17980421
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN2dc2b889-8443-4f7f-83be-86c68e17980421
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN2dc2b889-8443-4f7f-83be-86c68e17980421
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN2dc2b889-8443-4f7f-83be-86c68e17980421
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSN2dc2b889-8443-4f7f-83be-86c68e17980421
83122624 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule [Cartia]SBD2dc2b889-8443-4f7f-83be-86c68e17980421
83125524 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule [Cartia]SBD2dc2b889-8443-4f7f-83be-86c68e17980421
83130924 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule [Cartia]SBD2dc2b889-8443-4f7f-83be-86c68e17980421
83133824 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule [Cartia]SBD2dc2b889-8443-4f7f-83be-86c68e17980421
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD2dc2b889-8443-4f7f-83be-86c68e17980421
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD2dc2b889-8443-4f7f-83be-86c68e17980421
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD2dc2b889-8443-4f7f-83be-86c68e17980421
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCD2dc2b889-8443-4f7f-83be-86c68e17980421
83122624 HR Cartia 120 MG Extended Release Oral CapsuleSY2dc2b889-8443-4f7f-83be-86c68e17980421
83125524 HR Cartia 180 MG Extended Release Oral CapsuleSY2dc2b889-8443-4f7f-83be-86c68e17980421
83130924 HR Cartia 240 MG Extended Release Oral CapsuleSY2dc2b889-8443-4f7f-83be-86c68e17980421
83133824 HR Cartia 300 MG Extended Release Oral CapsuleSY2dc2b889-8443-4f7f-83be-86c68e17980421
831226Cartia 120 MG 24 HR Extended Release Oral CapsuleSY2dc2b889-8443-4f7f-83be-86c68e17980421
831255Cartia 180 MG 24 HR Extended Release Oral CapsuleSY2dc2b889-8443-4f7f-83be-86c68e17980421
831309Cartia 240 MG 24 HR Extended Release Oral CapsuleSY2dc2b889-8443-4f7f-83be-86c68e17980421
831338Cartia 300 MG 24 HR Extended Release Oral CapsuleSY2dc2b889-8443-4f7f-83be-86c68e17980421
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY2dc2b889-8443-4f7f-83be-86c68e17980421
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY2dc2b889-8443-4f7f-83be-86c68e17980421
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY2dc2b889-8443-4f7f-83be-86c68e17980421
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSY2dc2b889-8443-4f7f-83be-86c68e17980421
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
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
62037-597-0562037059705500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62037-597-05) 1999-06-230000-00-00NoNoCurrent
62037-597-906203705979090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62037-597-90) 1999-06-230000-00-00NoNoCurrent