FDA.reportPublic FDA data

DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE

Product NDC
44567-663
11-digit product format
445670663
Labeler code
44567
Product ID
44567-663_d3c2dae2-c1e5-469e-ad68-46fe6712d2c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diltiazem Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
NDA218038
Marketing category
NDA
Marketing start
2025-03-21
Substance
DILTIAZEM HYDROCHLORIDE
Active strength
1 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 in SODIUM CHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DILTIAZEM HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOLH94387TE
Rxcui2586036, 2709225

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
44567-663-01DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE250 mL in 1 BAGINJECTION, SOLUTION2503
44567-663-10DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE10 in 1 CARTONINJECTION, SOLUTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-663DILTIAZEM HYDROCHLORIDE IN SODIUM CHLORIDE (DILTIAZEM HYDROCHLORIDE) INJECTION, SOLUTION [WG CRITICAL CARE, LLC]3Current NDC, 2 package rows20250417_8bae87a5-2137-467e-a1ad-79b2bc075e07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2709225dilTIAZem hydrochloride 100 MG in 100 ML InjectionPSN8bae87a5-2137-467e-a1ad-79b2bc075e073
2586036dilTIAZem hydrochloride 250 MG in 250 ML InjectionPSN8bae87a5-2137-467e-a1ad-79b2bc075e073
2709225100 ML diltiazem hydrochloride 1 MG/ML InjectionSCD8bae87a5-2137-467e-a1ad-79b2bc075e073
2586036250 ML diltiazem hydrochloride 1 MG/ML InjectionSCD8bae87a5-2137-467e-a1ad-79b2bc075e073
2709225diltiazem hydrochloride 100 MG per 100 ML InjectionSY8bae87a5-2137-467e-a1ad-79b2bc075e073
2586036diltiazem hydrochloride 250 MG per 250 ML InjectionSY8bae87a5-2137-467e-a1ad-79b2bc075e073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
44567-663-0144567066301250 mL in 1 BAG250 mlHistorical
44567-663-104456706631010 BAG in 1 CARTON (44567-663-10) / 250 mL in 1 BAG (44567-663-01) 10 bag2025-03-21NoNoCurrent