Home NDC 51662-1335 DILTIAZEM HCI
Product NDC 51662-1335
11-digit product format 516621335
Labeler code 51662
Product ID 51662-1335_f2a0ac76-9d93-eaad-e053-2a95a90a4d67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DILTIAZEM HCI
Dosage form INJECTION
Route INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA078538
Marketing category ANDA
Marketing start 2018-12-21
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 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 A078538-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078538-001 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 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078538-001 DILTIAZEM HYDROCHLORIDE 5MG/ML INJECTABLE / INJECTION AP 2008-12-17 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 HCI
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1791229 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51662-1335-1 DILTIAZEM HCI 5 mL in 1 VIAL INJECTION 5 5 51662-1335-2 DILTIAZEM HCI 5 mL in 1 VIAL INJECTION 5 5 51662-1335-2 DILTIAZEM HCI 1 in 1 POUCH INJECTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1335 DILTIAZEM HCI INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 5 Current NDC, Legacy NDC, 3 package rows 20230120_7d8e8b1e-f67b-57d2-e053-2991aa0a8d12.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 · 4 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 51662-1335-1 51662133501 5 mL in 1 VIAL (51662-1335-1) 5 ml 2018-12-21 0000-00-00 No No Current 51662-1335-2 51662133502 1 VIAL in 1 POUCH (51662-1335-2) / 5 mL in 1 VIAL 1 vial 2023-01-19 No No Current