FDA.reportPublic FDA data

diltiazem hydrochloride

Product NDC
50742-251
11-digit product format
507420251
Labeler code
50742
Product ID
50742-251_d52d40db-f91a-49ea-ac2f-88a56f429421
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA208783
Marketing category
ANDA
Marketing start
2019-06-14
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
300 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 HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830795, 830801, 830837, 830845, 830861

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
50742-251-05diltiazem hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5006
50742-251-10diltiazem hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10006
50742-251-30diltiazem hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE306
50742-251-90diltiazem hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-251-30EA - Each50742-251b67a82d7-2555-4c17-b36e-221f1130d2a512020-09-14
50742-251-90EA - Each50742-25121dba915-281a-4b10-91d3-16940a94570212020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-251DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 4 package rows20231030_355f560a-8ebb-4661-ad74-2a22f707d7f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN355f560a-8ebb-4661-ad74-2a22f707d7f86
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN355f560a-8ebb-4661-ad74-2a22f707d7f86
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN355f560a-8ebb-4661-ad74-2a22f707d7f86
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSN355f560a-8ebb-4661-ad74-2a22f707d7f86
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSN355f560a-8ebb-4661-ad74-2a22f707d7f86
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD355f560a-8ebb-4661-ad74-2a22f707d7f86
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD355f560a-8ebb-4661-ad74-2a22f707d7f86
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD355f560a-8ebb-4661-ad74-2a22f707d7f86
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCD355f560a-8ebb-4661-ad74-2a22f707d7f86
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCD355f560a-8ebb-4661-ad74-2a22f707d7f86
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY355f560a-8ebb-4661-ad74-2a22f707d7f86
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY355f560a-8ebb-4661-ad74-2a22f707d7f86
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY355f560a-8ebb-4661-ad74-2a22f707d7f86
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSY355f560a-8ebb-4661-ad74-2a22f707d7f86
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSY355f560a-8ebb-4661-ad74-2a22f707d7f86
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSNf1ea85b2-ecd2-5867-e053-2a95a90a24dc3
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCDf1ea85b2-ecd2-5867-e053-2a95a90a24dc3
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYf1ea85b2-ecd2-5867-e053-2a95a90a24dc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-251-0550742025105500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-05) 2019-06-140000-00-00NoNoCurrent
50742-251-10507420251101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-10) 2019-06-140000-00-00NoNoCurrent
50742-251-305074202513030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-30) 2019-06-140000-00-00NoNoCurrent
50742-251-905074202519090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-90) 2019-06-140000-00-00NoNoCurrent