FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
55154-2627
11-digit product format
551542627
Labeler code
55154
Product ID
55154-2627_33bc3e75-69e6-408b-ac57-6a0f8c39d9bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA205231
Marketing category
ANDA
Marketing start
2023-08-01
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
240 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 HYDROCHLORIDE240 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui830837, 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
55154-2627-0Diltiazem Hydrochloride10 in 1 BAGCAPSULE, EXTENDED RELEASE106
55154-2627-0Diltiazem Hydrochloride1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2627DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH 107, LLC]3Current NDC, 2 package rows20241219_bdb9e7cf-bfbb-48b4-a8be-9038820d8279.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830861dilTIAZem HCl 120 MG 24HR Extended Release Oral CapsulePSNbdb9e7cf-bfbb-48b4-a8be-9038820d82796
830845dilTIAZem HCl 180 MG 24HR Extended Release Oral CapsulePSNbdb9e7cf-bfbb-48b4-a8be-9038820d82796
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSNbdb9e7cf-bfbb-48b4-a8be-9038820d82796
83086124 HR diltiazem hydrochloride 120 MG Extended Release Oral CapsuleSCDbdb9e7cf-bfbb-48b4-a8be-9038820d82796
83084524 HR diltiazem hydrochloride 180 MG Extended Release Oral CapsuleSCDbdb9e7cf-bfbb-48b4-a8be-9038820d82796
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCDbdb9e7cf-bfbb-48b4-a8be-9038820d82796
830861diltiazem HCl 120 MG 24 HR Extended Release Oral CapsuleSYbdb9e7cf-bfbb-48b4-a8be-9038820d82796
830845diltiazem HCl 180 MG 24 HR Extended Release Oral CapsuleSYbdb9e7cf-bfbb-48b4-a8be-9038820d82796
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSYbdb9e7cf-bfbb-48b4-a8be-9038820d82796

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-2627-05515426270010 BLISTER PACK in 1 BAG (55154-2627-0) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2023-08-01NoNoHistorical