FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
68682-368
11-digit product format
686820368
Labeler code
68682
Product ID
68682-368_f51e2ce0-22dd-4a31-bab8-70b0b55864af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
NDA020401
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-08-20
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
Brand name suffix
EXTENDED RELEASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE180 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830795, 830801, 830837, 830845, 830861, 831359

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
68682-368-90Diltiazem HydrochlorideEXTENDED RELEASE90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-368-90EA - Each68682-36832b9c335-c373-4d6e-b563-d25b81cd572912014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diltiazem hydrochlorideACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
DiltiazemACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
Ethyl Acrylate and Methyl Methacrylate Copolymer (2:1; 750000 MW)INACTIVE INGREDIENTP2OM2Q86BIDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
FD&C Green No. 3INACTIVE INGREDIENT3P3ONR6O1SDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
gelatinINACTIVE INGREDIENT2G86QN327LDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WODILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
magnesium stearateINACTIVE INGREDIENT70097M6I30DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
sucrose stearateINACTIVE INGREDIENT274KW0O50MDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
talcINACTIVE INGREDIENT7SEV7J4R1UDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-368DILTIAZEM HYDROCHLORIDE EXTENDED RELEASE (DILTIAZEM HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]7Current NDC, Legacy NDC, 1 package rows20201204_862d65cb-a732-4786-b569-bad2eaafddfd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN862d65cb-a732-4786-b569-bad2eaafddfd10
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN862d65cb-a732-4786-b569-bad2eaafddfd10
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN862d65cb-a732-4786-b569-bad2eaafddfd10
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSN862d65cb-a732-4786-b569-bad2eaafddfd10
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSN862d65cb-a732-4786-b569-bad2eaafddfd10
831359dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral CapsulePSN862d65cb-a732-4786-b569-bad2eaafddfd10
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD862d65cb-a732-4786-b569-bad2eaafddfd10
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD862d65cb-a732-4786-b569-bad2eaafddfd10
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD862d65cb-a732-4786-b569-bad2eaafddfd10
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCD862d65cb-a732-4786-b569-bad2eaafddfd10
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCD862d65cb-a732-4786-b569-bad2eaafddfd10
83135924 HR diltiazem hydrochloride 420 MG Extended Release Oral CapsuleSCD862d65cb-a732-4786-b569-bad2eaafddfd10
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY862d65cb-a732-4786-b569-bad2eaafddfd10
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY862d65cb-a732-4786-b569-bad2eaafddfd10
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY862d65cb-a732-4786-b569-bad2eaafddfd10
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSY862d65cb-a732-4786-b569-bad2eaafddfd10
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSY862d65cb-a732-4786-b569-bad2eaafddfd10
831359diltiazem hydrochloride 420 MG 24 HR Extended Release Oral CapsuleSY862d65cb-a732-4786-b569-bad2eaafddfd10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-368-906868203689090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68682-368-90) 2014-08-200000-00-00NoNoCurrent