Home NDC 25021-319 Diltiazem Hydrochloride
Product NDC 25021-319
11-digit product format 250210319
Labeler code 25021
Product ID 25021-319_13a2c20f-bf6f-4dad-938e-6f4ff99a689a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diltiazem hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application ANDA074617
Marketing category ANDA
Marketing start 2024-06-01
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 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 A074617-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074617-001 AP
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 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074617-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP RS 1996-02-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Diltiazem Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DILTIAZEM HYDROCHLORIDE 5 mg/mL
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1791229 Internal RxNorm lookup 1791232 Internal RxNorm lookup 1791233 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 25021-319-05 Diltiazem Hydrochloride 5 mL in 1 VIAL INJECTION, SOLUTION 5 1 25021-319-05 Diltiazem Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 1 25021-319-10 Diltiazem Hydrochloride 10 mL in 1 VIAL INJECTION, SOLUTION 10 1 25021-319-10 Diltiazem Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 1 25021-319-25 Diltiazem Hydrochloride 25 mL in 1 VIAL INJECTION, SOLUTION 25 1 25021-319-25 Diltiazem Hydrochloride 10 in 1 CARTON INJECTION, SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25021-319 DILTIAZEM HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] 1 Current NDC, 6 package rows 20240601_9d51c0f6-26b7-4220-83fb-4e736b289e64.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 25021-319-05 25021031905 10 VIAL in 1 CARTON (25021-319-05) / 5 mL in 1 VIAL 10 vial 2024-06-01 No No Current 25021-319-10 25021031910 10 VIAL in 1 CARTON (25021-319-10) / 10 mL in 1 VIAL 10 vial 2024-06-01 No No Current 25021-319-25 25021031925 10 VIAL in 1 CARTON (25021-319-25) / 25 mL in 1 VIAL 10 vial 2024-06-01 No No Current