FDA.reportPublic FDA data

DILTIAZEM HYDROCHLORIDE

Product NDC
60505-0015
11-digit product format
605050015
Labeler code
60505
Product ID
60505-0015_e06c5d5f-878e-6bb1-793c-642751592404
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DILTIAZEM HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA074943
Marketing category
ANDA
Marketing start
2001-07-30
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
180 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
DILTIAZEM HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830837, 830845, 830861, 831215, 831252, 831285

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
60505-0015-6DILTIAZEM HYDROCHLORIDE100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1008
60505-0015-8DILTIAZEM HYDROCHLORIDE500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0015-6EA - Each60505-001531194802-0c0f-4713-898d-f84d9df0b0f112012-07-24
60505-0015-8EA - Each60505-0015e4d25c0e-705b-44b3-ae68-906c10f5deeb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DILTIAZEM HYDROCHLORIDEACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
DILTIAZEMACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
GELATININACTIVE INGREDIENT2G86QN327LDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0015DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APOTEX CORP.]7Current NDC, Legacy NDC, 2 package rows20240926_56573e9d-7bd2-694c-cd6d-26039590e548.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831215DILT-CD 120 MG 24HR Extended Release Oral CapsulePSN56573e9d-7bd2-694c-cd6d-26039590e5488
831252DILT-CD 180 MG 24HR Extended Release Oral CapsulePSN56573e9d-7bd2-694c-cd6d-26039590e5488
831285DILT-CD 240 MG 24HR Extended Release Oral CapsulePSN56573e9d-7bd2-694c-cd6d-26039590e5488
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN56573e9d-7bd2-694c-cd6d-26039590e5488
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN56573e9d-7bd2-694c-cd6d-26039590e5488
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN56573e9d-7bd2-694c-cd6d-26039590e5488
83121524 HR diltiazem hydrochloride 120 MG Extended Release Oral Capsule [Dilt]SBD56573e9d-7bd2-694c-cd6d-26039590e5488
83125224 HR diltiazem hydrochloride 180 MG Extended Release Oral Capsule [Dilt]SBD56573e9d-7bd2-694c-cd6d-26039590e5488
83128524 HR diltiazem hydrochloride 240 MG Extended Release Oral Capsule [Dilt]SBD56573e9d-7bd2-694c-cd6d-26039590e5488
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD56573e9d-7bd2-694c-cd6d-26039590e5488
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD56573e9d-7bd2-694c-cd6d-26039590e5488
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD56573e9d-7bd2-694c-cd6d-26039590e5488
83121524 HR Dilt 120 MG Extended Release Oral CapsuleSY56573e9d-7bd2-694c-cd6d-26039590e5488
83125224 HR Dilt 180 MG Extended Release Oral CapsuleSY56573e9d-7bd2-694c-cd6d-26039590e5488
83128524 HR Dilt 240 MG Extended Release Oral CapsuleSY56573e9d-7bd2-694c-cd6d-26039590e5488
831215Dilt 120 MG 24 HR Extended Release Oral CapsuleSY56573e9d-7bd2-694c-cd6d-26039590e5488
831252Dilt 180 MG 24 HR Extended Release Oral CapsuleSY56573e9d-7bd2-694c-cd6d-26039590e5488
831285Dilt 240 MG 24 HR Extended Release Oral CapsuleSY56573e9d-7bd2-694c-cd6d-26039590e5488
831252Dilt-XR 180 MG 24 HR Extended Release Oral CapsuleSY56573e9d-7bd2-694c-cd6d-26039590e5488
831285Dilt-XR 240 MG 24 HR Extended Release Oral CapsuleSY56573e9d-7bd2-694c-cd6d-26039590e5488
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY56573e9d-7bd2-694c-cd6d-26039590e5488
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY56573e9d-7bd2-694c-cd6d-26039590e5488
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY56573e9d-7bd2-694c-cd6d-26039590e5488
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN3a620125-898a-47ba-9000-4295c3a3ad726
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD3a620125-898a-47ba-9000-4295c3a3ad726
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY3a620125-898a-47ba-9000-4295c3a3ad726
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSNb7e0adf6-f1ab-432f-a632-0fbbfc5197925
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCDb7e0adf6-f1ab-432f-a632-0fbbfc5197925
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSYb7e0adf6-f1ab-432f-a632-0fbbfc5197925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0015-660505001506100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-0015-6) 2001-07-300000-00-00NoNoCurrent
60505-0015-860505001508500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-0015-8) 2001-07-300000-00-00NoNoCurrent