Home NDC 51662-1457-3 DILTIAZEM HCI
Product NDC 51662-1457
Requested package NDC 51662-1457-3
11-digit product format 516621457
Labeler code 51662
Product ID 51662-1457_132cd9f9-a36c-4e35-e063-6294a90aaa17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DILTIAZEM HCI
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA075853
Marketing category ANDA
Marketing start 2019-12-15
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
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 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 HCI
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 51662-1457-1 DILTIAZEM HCI 1 in 1 VIAL, PATENT DELIVERY SYSTEM INJECTION, POWDER, LYOPHILIZED, 1 5 51662-1457-2 DILTIAZEM HCI 1 in 1 VIAL, PATENT DELIVERY SYSTEM INJECTION, POWDER, LYOPHILIZED, 1 5 51662-1457-2 DILTIAZEM HCI 1 in 1 POUCH INJECTION, POWDER, LYOPHILIZED, 1 5 51662-1457-3 DILTIAZEM HCI 10 in 1 CASE INJECTION, POWDER, LYOPHILIZED, 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1457 DILTIAZEM HCI INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 5 Current NDC, Legacy NDC, 4 package rows 20240310_99c5813f-1ffe-0eaa-e053-2a95a90a751b.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 Units Marketing start Marketing end Sample Exclude flag Status 51662-1457-3 51662145703 10 POUCH in 1 CASE (51662-1457-3) / 1 VIAL, PATENT DELIVERY SYSTEM in 1 POUCH (51662-1457-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM 10 pouch 2022-12-11 0000-00-00 No No Current