Home NDC 0409-4350 Diltiazem Hydrochloride
Product NDC 0409-4350
11-digit product format 004094350
Labeler code 0409
Product ID 0409-4350_9e518c0c-b7a9-457c-9ca5-6b6c132f985e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DILTIAZEM HYDROCHLORIDE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA075853
Marketing category ANDA
Marketing start 2005-04-30
Marketing end 2026-12-31
Substance DILTIAZEM HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag No
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Diltiazem Hydrochloride Active Ingredients# Ingredient, Strength table Ingredient Strength DILTIAZEM HYDROCHLORIDE 100 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii OLH94387TE Rxcui 1791230, 1791240
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-4350-03 Diltiazem Hydrochloride 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 21 0409-4350-13 Diltiazem Hydrochloride 1 in 1 VIAL, PATENT DELIVERY SYSTEM INJECTION, POWDER, LYOPHILIZED, 1 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DILTIAZEM HYDROCHLORIDE ACTIVE INGREDIENT OLH94387TE DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 10 DILTIAZEM ACTIVE MOIETY EE92BBP03H DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 10 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 10 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 10 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 10 SORBITOL INACTIVE INGREDIENT 506T60A25R DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 10 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 10 WATER INACTIVE INGREDIENT 059QF0KO0R DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-4350 DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION DILTIAZEM HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 20 Current NDC, Legacy NDC, 2 package rows 20230118_bba03666-ff4f-4bf6-fa92-78e1ec2d9073.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0409-4350-03 00409435003 10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY (0409-4350-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-4350-13) 2005-04-30 2026-12-31 No No Current 0409-4350-13 00409435013 1 in 1 VIAL, PATENT DELIVERY SYSTEM Historical