Diltiazem Hydrochloride

Product NDC
68682-706
11-digit product format
686820706
Labeler code
68682
Product ID
68682-706_9c3468f2-1199-4180-9e57-089b5353251a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride Extended-Release Tablets
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
NDA021392
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-02-06
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
240 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 HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830874, 830877, 830879, 830882, 830897, 830900

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
68682-706-30Diltiazem Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3010
68682-706-90Diltiazem Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-706-30EA - Each68682-7067b058ef4-6f68-465a-a9dd-8ce957c2619e12014-04-03
68682-706-90EA - Each68682-706516a3744-b77a-4abf-95dd-8c5ae61d2a3012014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diltiazem HydrochlorideACTIVE INGREDIENTOLH94387TEDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
DiltiazemACTIVE MOIETYEE92BBP03HDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
ethyl acrylate and methyl methacrylate copolymer (2:1; 750000 mw)INACTIVE INGREDIENTP2OM2Q86BIDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WODILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
microcrystalline waxINACTIVE INGREDIENTXOF597Q3KYDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
polydextroseINACTIVE INGREDIENTVH2XOU12IEDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
sucrose stearateINACTIVE INGREDIENT274KW0O50MDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
talcINACTIVE INGREDIENT7SEV7J4R1UDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-706DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, EXTENDED RELEASE [OCEANSIDE PHARMACEUTICALS]9Current NDC, Legacy NDC, 2 package rows20230331_73b3607a-99d0-44d8-92ef-0074684c9d7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830874dilTIAZem hydrochloride 120 MG 24HR Extended Release Oral TabletPSN73b3607a-99d0-44d8-92ef-0074684c9d7d10
830877dilTIAZem hydrochloride 180 MG 24HR Extended Release Oral TabletPSN73b3607a-99d0-44d8-92ef-0074684c9d7d10
830879dilTIAZem hydrochloride 240 MG 24HR Extended Release Oral TabletPSN73b3607a-99d0-44d8-92ef-0074684c9d7d10
830882dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral TabletPSN73b3607a-99d0-44d8-92ef-0074684c9d7d10
830897dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral TabletPSN73b3607a-99d0-44d8-92ef-0074684c9d7d10
830900dilTIAZem hydrochloride 420 MG 24HR Extended Release Oral TabletPSN73b3607a-99d0-44d8-92ef-0074684c9d7d10
83087424 HR diltiazem hydrochloride 120 MG Extended Release Oral TabletSCD73b3607a-99d0-44d8-92ef-0074684c9d7d10
83087724 HR diltiazem hydrochloride 180 MG Extended Release Oral TabletSCD73b3607a-99d0-44d8-92ef-0074684c9d7d10
83087924 HR diltiazem hydrochloride 240 MG Extended Release Oral TabletSCD73b3607a-99d0-44d8-92ef-0074684c9d7d10
83088224 HR diltiazem hydrochloride 300 MG Extended Release Oral TabletSCD73b3607a-99d0-44d8-92ef-0074684c9d7d10
83089724 HR diltiazem hydrochloride 360 MG Extended Release Oral TabletSCD73b3607a-99d0-44d8-92ef-0074684c9d7d10
83090024 HR diltiazem hydrochloride 420 MG Extended Release Oral TabletSCD73b3607a-99d0-44d8-92ef-0074684c9d7d10
830874diltiazem hydrochloride 120 MG 24 HR Extended Release Oral TabletSY73b3607a-99d0-44d8-92ef-0074684c9d7d10
830877diltiazem hydrochloride 180 MG 24 HR Extended Release Oral TabletSY73b3607a-99d0-44d8-92ef-0074684c9d7d10
830879diltiazem hydrochloride 240 MG 24 HR Extended Release Oral TabletSY73b3607a-99d0-44d8-92ef-0074684c9d7d10
830882diltiazem hydrochloride 300 MG 24 HR Extended Release Oral TabletSY73b3607a-99d0-44d8-92ef-0074684c9d7d10
830897diltiazem hydrochloride 360 MG 24 HR Extended Release Oral TabletSY73b3607a-99d0-44d8-92ef-0074684c9d7d10
830900diltiazem hydrochloride 420 MG 24 HR Extended Release Oral TabletSY73b3607a-99d0-44d8-92ef-0074684c9d7d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-706-306868207063030 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-706-30) 2014-02-060000-00-00NoNoCurrent
68682-706-906868207069090 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-706-90) 2014-02-060000-00-00NoNoCurrent