FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
24979-183
11-digit product format
249790183
Labeler code
24979
Product ID
24979-183_515b321d-2983-49dd-bccd-4e4e375e33c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA217377
Marketing category
ANDA
Marketing start
2023-05-01
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
120 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830865, 830869, 830872

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
24979-183-01Diltiazem Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-183-01EA - Each24979-183de8365e5-a9d0-4432-8d37-d8a774c385d912024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-183DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]9Current NDC, 1 package rows20250410_f276d9fe-a685-4d99-ad82-d4452ef4ba98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830872dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral CapsulePSNf276d9fe-a685-4d99-ad82-d4452ef4ba9810
830865dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral CapsulePSNf276d9fe-a685-4d99-ad82-d4452ef4ba9810
830869dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral CapsulePSNf276d9fe-a685-4d99-ad82-d4452ef4ba9810
83087212 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDf276d9fe-a685-4d99-ad82-d4452ef4ba9810
83086512 HR diltiazem hydrochloride 60 MG Extended Release Oral CapsuleSCDf276d9fe-a685-4d99-ad82-d4452ef4ba9810
83086912 HR diltiazem hydrochloride 90 MG Extended Release Oral CapsuleSCDf276d9fe-a685-4d99-ad82-d4452ef4ba9810
830872diltiazem hydrochloride 120 MG 12 HR Extended Release Oral CapsuleSYf276d9fe-a685-4d99-ad82-d4452ef4ba9810
830865diltiazem hydrochloride 60 MG 12 HR Extended Release Oral CapsuleSYf276d9fe-a685-4d99-ad82-d4452ef4ba9810
830869diltiazem hydrochloride 90 MG 12 HR Extended Release Oral CapsuleSYf276d9fe-a685-4d99-ad82-d4452ef4ba9810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24979-183-0124979018301100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24979-183-01) 2023-05-01NoNoCurrent