FDA.reportPublic FDA data

Diltiazem Hydrochloride

Product NDC
50090-5452
11-digit product format
500905452
Labeler code
50090
Product ID
50090-5452_ff233e17-a4bc-4258-829c-36f5756a13b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA205231
Marketing category
ANDA
Marketing start
2018-10-01
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5452-02023-02-06C16284748780-1f386c64a-1f23-0266-e053-dadaa90a7c1aDiltiazem ER CapsulesRx only
50090-5452-12023-02-06C16284748780-1f386c64a-1f23-0266-e053-dadaa90a7c1aDiltiazem ER CapsulesRx only
50090-5452-02023-01-30C16284748780-1f386c64a-1f23-0266-e053-dadaa90a7c1aDiltiazem ER CapsulesRx only
50090-5452-12023-01-30C16284748780-1f386c64a-1f23-0266-e053-dadaa90a7c1aDiltiazem ER CapsulesRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5452-0Diltiazem Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3012
50090-5452-1Diltiazem Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5452-0EA - Each50090-54522352dc5c-5894-453f-9f4d-8ecd99bd2bf212023-08-08
50090-5452-1EA - Each50090-54529e535f00-a1aa-4400-ba87-e496532ac78b12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5452DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20240731_839af3af-4040-4cf4-8d4a-881a053514cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
830837dilTIAZem HCl 240 MG 24HR Extended Release Oral CapsulePSN839af3af-4040-4cf4-8d4a-881a053514cc12
83083724 HR diltiazem hydrochloride 240 MG Extended Release Oral CapsuleSCD839af3af-4040-4cf4-8d4a-881a053514cc12
830837diltiazem HCl 240 MG 24 HR Extended Release Oral CapsuleSY839af3af-4040-4cf4-8d4a-881a053514cc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5452-05009054520030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5452-0) 2021-01-260000-00-00NoNoCurrent
50090-5452-15009054520190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5452-1) 2021-01-260000-00-00NoNoCurrent