diltiazem hydrochloride

Product NDC
68151-1480
11-digit product format
681511480
Labeler code
68151
Product ID
68151-1480_2ea63016-53e3-4a80-8668-fb36550906ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA020401
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-09-25
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
2017-12-31
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
68151-1480-92020-01-31C16284748780-19d75b9d0-78c1-f424-e053-dadaa90a57ceDiltiazem Hydrochloride Extended-Release Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-1480-9diltiazem hydrochloride1 in 1 PACKAGECAPSULE, EXTENDED RELEASE13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DILTIAZEM HYDROCHLORIDEACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
DILTIAZEMACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
ETHYL ACRYLATEINACTIVE INGREDIENT71E6178C9TDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SUCROSE STEARATEINACTIVE INGREDIENT274KW0O50MDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-1480DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_66d650f4-93dc-4aa2-8908-f87d6691a875.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN66d650f4-93dc-4aa2-8908-f87d6691a8753
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD66d650f4-93dc-4aa2-8908-f87d6691a8753
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY66d650f4-93dc-4aa2-8908-f87d6691a8753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-1480-9681511480091 in 1 PACKAGEHistorical