Diltiazem Hydrochloride

Product NDC
62135-335
11-digit product format
621350335
Labeler code
62135
Product ID
62135-335_1b432d9d-b46c-2ee8-e063-6294a90adb54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA074093
Marketing category
ANDA
Marketing start
1992-11-05
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
90 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 HYDROCHLORIDE90 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
62135-335-90Diltiazem Hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-335-90EA - Each62135-335e9170853-40ff-4c9a-b04e-6b66c11ac10d12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-335DILTIAZEM HYDROCHLORIDE TABLET [CHARTWELL RX, LLC]1Current NDC, 1 package rows20240622_51abce7b-e3d1-44b5-bccc-d463150d0bba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831102dilTIAZem HCl 90 MG Oral TabletPSN51abce7b-e3d1-44b5-bccc-d463150d0bba1
831054dilTIAZem hydrochloride 120 MG Oral TabletPSN51abce7b-e3d1-44b5-bccc-d463150d0bba1
833217dilTIAZem hydrochloride 30 MG Oral TabletPSN51abce7b-e3d1-44b5-bccc-d463150d0bba1
831103dilTIAZem hydrochloride 60 MG Oral TabletPSN51abce7b-e3d1-44b5-bccc-d463150d0bba1
831054diltiazem hydrochloride 120 MG Oral TabletSCD51abce7b-e3d1-44b5-bccc-d463150d0bba1
833217diltiazem hydrochloride 30 MG Oral TabletSCD51abce7b-e3d1-44b5-bccc-d463150d0bba1
831103diltiazem hydrochloride 60 MG Oral TabletSCD51abce7b-e3d1-44b5-bccc-d463150d0bba1
831102diltiazem hydrochloride 90 MG Oral TabletSCD51abce7b-e3d1-44b5-bccc-d463150d0bba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-335-906213503359090 TABLET in 1 BOTTLE (62135-335-90) 90 tablet2024-06-17NoNoHistorical