Diltiazem Hydrochloride

Product NDC
62332-784
11-digit product format
623320784
Labeler code
62332
Product ID
62332-784_2180c38c-9155-4c89-83c0-ea9e0bb568fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA217633
Marketing category
ANDA
Marketing start
2025-11-14
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE120 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
62332-784-31Diltiazem Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1005
62332-784-71Diltiazem Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
831102dilTIAZem HCl 90 MG Oral TabletPSNab38794a-914d-4bcd-9c6d-1578aa10041a5
831054dilTIAZem hydrochloride 120 MG Oral TabletPSNab38794a-914d-4bcd-9c6d-1578aa10041a5
833217dilTIAZem hydrochloride 30 MG Oral TabletPSNab38794a-914d-4bcd-9c6d-1578aa10041a5
831103dilTIAZem hydrochloride 60 MG Oral TabletPSNab38794a-914d-4bcd-9c6d-1578aa10041a5
831054diltiazem hydrochloride 120 MG Oral TabletSCDab38794a-914d-4bcd-9c6d-1578aa10041a5
833217diltiazem hydrochloride 30 MG Oral TabletSCDab38794a-914d-4bcd-9c6d-1578aa10041a5
831103diltiazem hydrochloride 60 MG Oral TabletSCDab38794a-914d-4bcd-9c6d-1578aa10041a5
831102diltiazem hydrochloride 90 MG Oral TabletSCDab38794a-914d-4bcd-9c6d-1578aa10041a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-784-3162332078431100 TABLET, FILM COATED in 1 BOTTLE (62332-784-31) 2025-11-14NoNoCurrent
62332-784-7162332078471500 TABLET, FILM COATED in 1 BOTTLE (62332-784-71) 2025-11-14NoNoCurrent