diltiazem hydrochloride

Product NDC
68151-2113
11-digit product format
681512113
Labeler code
68151
Product ID
68151-2113_9789e1e1-3c69-454e-8309-59ffecfe60d1
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
240 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
68151-2113-92020-01-31C16284748780-19d75b9d0-fcf1-f424-e053-dadaa90a57ceDiltiazem Hydrochloride Extended-Release Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-2113-9diltiazem 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
68151-2113DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_ef28a98e-946f-441d-b666-a3e669b13f20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNef28a98e-946f-441d-b666-a3e669b13f203
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDef28a98e-946f-441d-b666-a3e669b13f203
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYef28a98e-946f-441d-b666-a3e669b13f203

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-2113-9681512113091 in 1 PACKAGEHistorical