FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
68682-998
11-digit product format
686820998
Labeler code
68682
Product ID
68682-998_c44f803b-1698-4e4f-845f-ae0f54c9d121
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
OCEANSIDE PHARMACEUTICALS
Application
ANDA075116
Marketing category
ANDA
Marketing start
1999-12-28
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
300 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 HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830801, 830837, 830845, 830861

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
68682-998-98Diltiazem Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-998-98EA - Each68682-998d2fc23e0-c0fb-487f-83c7-2812273b2a4c12015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diltiazem HydrochlorideACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
DiltiazemACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
D&C Yellow no. 10INACTIVE INGREDIENT35SW5USQ3GDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
FD&C Green no. 3INACTIVE INGREDIENT3P3ONR6O1SDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
GelatinINACTIVE INGREDIENT2G86QN327LDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WODILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
SUCROSE STEARATEINACTIVE INGREDIENT274KW0O50MDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
TalcINACTIVE INGREDIENT7SEV7J4R1UDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-998DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]5Current NDC, Legacy NDC, 1 package rows20191105_43892b97-449d-45bc-bb09-29d47c655d65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN43892b97-449d-45bc-bb09-29d47c655d658
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN43892b97-449d-45bc-bb09-29d47c655d658
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN43892b97-449d-45bc-bb09-29d47c655d658
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSN43892b97-449d-45bc-bb09-29d47c655d658
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD43892b97-449d-45bc-bb09-29d47c655d658
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD43892b97-449d-45bc-bb09-29d47c655d658
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD43892b97-449d-45bc-bb09-29d47c655d658
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCD43892b97-449d-45bc-bb09-29d47c655d658
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY43892b97-449d-45bc-bb09-29d47c655d658
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY43892b97-449d-45bc-bb09-29d47c655d658
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY43892b97-449d-45bc-bb09-29d47c655d658
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSY43892b97-449d-45bc-bb09-29d47c655d658
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSNefe88e54-9552-4169-8749-065f543cc2603
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCDefe88e54-9552-4169-8749-065f543cc2603
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYefe88e54-9552-4169-8749-065f543cc2603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-998-986868209989890 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68682-998-98) 1999-12-280000-00-00NoNoCurrent