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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075853-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075853-001 DILTIAZEM HYDROCHLORIDE 100MG/VIAL INJECTABLE / INJECTION RS 2002-12-17 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Diltiazem Hydrochloride Active Ingredients# Ingredient, Strength table Ingredient Strength DILTIAZEM HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination OLH94387TE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1791230 Internal RxNorm lookup 1791240 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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