FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
50742-565
11-digit product format
507420565
Labeler code
50742
Product ID
50742-565_3dd3b71c-60fb-45a2-866e-7761f1c48aa3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA218032
Marketing category
ANDA
Marketing start
2025-07-03
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
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
50742-565-01Diltiazem Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE1001
50742-565-05Diltiazem Hydrochloride500 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-565-01EA - Each50742-565d693b73b-f442-486a-b023-d6ebde5027eb12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830872dilTIAZem hydrochloride 120 MG 12HR Extended Release Oral CapsulePSN64401d2a-bd5b-43fd-879a-e9d16345e8271
830865dilTIAZem hydrochloride 60 MG 12HR Extended Release Oral CapsulePSN64401d2a-bd5b-43fd-879a-e9d16345e8271
830869dilTIAZem hydrochloride 90 MG 12HR Extended Release Oral CapsulePSN64401d2a-bd5b-43fd-879a-e9d16345e8271
83087212 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD64401d2a-bd5b-43fd-879a-e9d16345e8271
83086512 HR diltiazem hydrochloride 60 MG Extended Release Oral CapsuleSCD64401d2a-bd5b-43fd-879a-e9d16345e8271
83086912 HR diltiazem hydrochloride 90 MG Extended Release Oral CapsuleSCD64401d2a-bd5b-43fd-879a-e9d16345e8271
830872diltiazem hydrochloride 120 MG 12 HR Extended Release Oral CapsuleSY64401d2a-bd5b-43fd-879a-e9d16345e8271
830865diltiazem hydrochloride 60 MG 12 HR Extended Release Oral CapsuleSY64401d2a-bd5b-43fd-879a-e9d16345e8271
830869diltiazem hydrochloride 90 MG 12 HR Extended Release Oral CapsuleSY64401d2a-bd5b-43fd-879a-e9d16345e8271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50742-565-0150742056501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-565-01) 2025-07-03NoNoCurrent
50742-565-0550742056505500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-565-05) 2025-07-03NoNoCurrent