FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
68682-007
11-digit product format
686820007
Labeler code
68682
Product ID
68682-007_06626a5d-987f-4d1c-9ffc-28fd51362900
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Oceanside Pharmaceuticals
Application
NDA018602
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-12-25
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]
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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui831054, 831102, 831103, 833217

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
68682-007-10Diltiazem Hydrochloride100 in 1 BOTTLETABLET1009
68682-007-50Diltiazem Hydrochloride500 in 1 BOTTLETABLET5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-007-10EA - Each68682-007d58e83ec-b420-4fe2-bb87-3df28ea21c6612016-12-07
68682-007-50EA - Each68682-00758c93ea1-f75a-491e-a6bb-70163723776912016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-007DILTIAZEM HYDROCHLORIDE TABLET DILTIAZEM HYDROCHLORIDE TABLET [OCEANSIDE PHARMACEUTICALS]9Current NDC, Legacy NDC, 2 package rows20230329_f6a24de7-8ffe-48af-873f-10fdcd5551d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831103dilTIAZem hydrochloride 60 MG Oral TabletPSN13bfcfc6-deb9-439f-98ec-85a2b94b4a8a100
831103diltiazem hydrochloride 60 MG Oral TabletSCD13bfcfc6-deb9-439f-98ec-85a2b94b4a8a100
831102dilTIAZem HCl 90 MG Oral TabletPSNf6a24de7-8ffe-48af-873f-10fdcd5551d19
831054dilTIAZem hydrochloride 120 MG Oral TabletPSNf6a24de7-8ffe-48af-873f-10fdcd5551d19
833217dilTIAZem hydrochloride 30 MG Oral TabletPSNf6a24de7-8ffe-48af-873f-10fdcd5551d19
831103dilTIAZem hydrochloride 60 MG Oral TabletPSNf6a24de7-8ffe-48af-873f-10fdcd5551d19
831054diltiazem hydrochloride 120 MG Oral TabletSCDf6a24de7-8ffe-48af-873f-10fdcd5551d19
833217diltiazem hydrochloride 30 MG Oral TabletSCDf6a24de7-8ffe-48af-873f-10fdcd5551d19
831103diltiazem hydrochloride 60 MG Oral TabletSCDf6a24de7-8ffe-48af-873f-10fdcd5551d19
831102diltiazem hydrochloride 90 MG Oral TabletSCDf6a24de7-8ffe-48af-873f-10fdcd5551d19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68682-007-1068682000710100 TABLET in 1 BOTTLE (68682-007-10) 100 tablet2010-12-250000-00-00NoNoCurrent
68682-007-5068682000750500 TABLET in 1 BOTTLE (68682-007-50) 500 tablet2010-12-250000-00-00NoNoCurrent