FDA.reportPublic FDA data

DILTIAZEM HYDROCHLORIDE

Product NDC
55150-427
11-digit product format
551500427
Labeler code
55150
Product ID
55150-427_cb4e6bde-c44b-4e66-b565-cf955d311756
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diltiazem hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA216552
Marketing category
ANDA
Marketing start
2023-03-29
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
5 mg/mL
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 HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui1791229, 1791232, 1791233

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
55150-427-01DILTIAZEM HYDROCHLORIDE25 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION253
55150-427-10DILTIAZEM HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-427-01ML - Milliliter55150-427cf1fa930-4b5d-4a4a-96b7-03b494ff347c12023-07-06
55150-427-10ML - Milliliter55150-427717f5cd0-862d-4eaa-a10e-7fc0ce0a714512023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-427DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]2Current NDC, 2 package rows20230407_f8d962ab-6cd4-43a1-a8fa-fb6548ac2a08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791233dilTIAZem hydrochloride 125 MG in 25 mL InjectionPSNf8d962ab-6cd4-43a1-a8fa-fb6548ac2a083
1791229dilTIAZem hydrochloride 25 MG in 5 mL InjectionPSNf8d962ab-6cd4-43a1-a8fa-fb6548ac2a083
1791232dilTIAZem hydrochloride 50 MG in 10 mL InjectionPSNf8d962ab-6cd4-43a1-a8fa-fb6548ac2a083
179123210 ML diltiazem hydrochloride 5 MG/ML InjectionSCDf8d962ab-6cd4-43a1-a8fa-fb6548ac2a083
179123325 ML diltiazem hydrochloride 5 MG/ML InjectionSCDf8d962ab-6cd4-43a1-a8fa-fb6548ac2a083
17912295 ML diltiazem hydrochloride 5 MG/ML InjectionSCDf8d962ab-6cd4-43a1-a8fa-fb6548ac2a083
1791233diltiazem hydrochloride 125 MG per 25 ML InjectionSYf8d962ab-6cd4-43a1-a8fa-fb6548ac2a083
1791229diltiazem hydrochloride 25 MG per 5 ML InjectionSYf8d962ab-6cd4-43a1-a8fa-fb6548ac2a083
1791232diltiazem hydrochloride 50 MG per 10 ML InjectionSYf8d962ab-6cd4-43a1-a8fa-fb6548ac2a083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55150-427-015515004270125 mL in 1 VIAL, SINGLE-DOSE25 mlHistorical
55150-427-105515004271010 VIAL, SINGLE-DOSE in 1 CARTON (55150-427-10) / 25 mL in 1 VIAL, SINGLE-DOSE (55150-427-01) 2023-03-29NoNoHistorical