Home NDC 0409-1171 Diltiazem Hydrochloride
Product NDC 0409-1171
11-digit product format 004091171
Labeler code 0409
Product ID 0409-1171_5e51477c-3362-4911-b807-aea83af23c27
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diltiazem Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA074941
Marketing category ANDA
Marketing start 2006-05-05
Marketing end 0000-00-00
Substance DILTIAZEM HYDROCHLORIDE
Active strength 5 mg/mL
Pharmacologic classes Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A074941-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 1998-04-15
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 · 43 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 2026-09-14 22:38:34 2026-08 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 1998-04-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 1998-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 1998-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION 1998-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074941-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 1998-04-15 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-1171-01 Diltiazem Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 21 0409-1171-02 Diltiazem Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 21 0409-1171-11 Diltiazem Hydrochloride 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 21 0409-1171-12 Diltiazem Hydrochloride 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 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 0409-1171 DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION DILTIAZEM HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] 20 Legacy NDC, 4 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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0409-1171-01 00409117101 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1171-01) > 5 mL in 1 VIAL, SINGLE-DOSE (0409-1171-11) 2006-09-13 0000-00-00 No No Current 0409-1171-02 00409117102 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1171-02) > 10 mL in 1 VIAL, SINGLE-DOSE (0409-1171-12) 2006-05-05 0000-00-00 No No Current 0409-1171-11 00409117111 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 0409-1171-12 00409117112 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical