FDA.reportPublic FDA data

Diltiazem hydrochloride

Product NDC
63304-722
11-digit product format
633040722
Labeler code
63304
Product ID
63304-722_35b4a94c-9d26-e406-e063-6394a90aa9fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA203023
Marketing category
ANDA
Marketing start
2018-10-31
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
360 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 HYDROCHLORIDE360 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
63304-722-05Diltiazem hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50010
63304-722-30Diltiazem hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010
63304-722-90Diltiazem hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-722-90EA - Each63304-72266264fc0-b728-40d5-b2c2-e4b63701323c12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-722DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]10Current NDC, Legacy NDC, 3 package rows20250523_976d9dd0-4f11-4439-b84e-0c0f0e018d8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSN976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSN976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830801dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral CapsulePSN976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830795dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral CapsulePSN976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCD976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCD976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
83080124 HR diltiazem hydrochloride 300 MG Extended Release Oral CapsuleSCD976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
83079524 HR diltiazem hydrochloride 360 MG Extended Release Oral CapsuleSCD976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSY976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSY976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830801diltiazem hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSY976d9dd0-4f11-4439-b84e-0c0f0e018d8b10
830795diltiazem hydrochloride 360 MG 24 HR Extended Release Oral CapsuleSY976d9dd0-4f11-4439-b84e-0c0f0e018d8b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63304-722-0563304072205500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-722-05) 2018-10-310000-00-00NoNoCurrent
63304-722-306330407223030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-722-30) 2018-10-310000-00-00NoNoCurrent
63304-722-906330407229090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-722-90) 2018-10-310000-00-00NoNoCurrent