Home NDC 0641-9218 Diltiazem Hydrochloride
Product NDC 0641-9218
11-digit product format 006419218
Labeler code 0641
Product ID 0641-9218_82ec8594-72c0-4636-9b36-74fe724f750e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diltiazem Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA078538
Marketing category ANDA
Marketing start 2008-12-17
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 2027-12-31
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 Hydrochloride
Listing expiration 2027-12-31 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 0641-9218-01 Diltiazem Hydrochloride 10 mL in 1 VIAL INJECTION 10 6 0641-9218-10 Diltiazem Hydrochloride 10 in 1 CARTON INJECTION 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-9218 DILTIAZEM HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240410_734beeef-3968-4137-af2c-276e8a9317df.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 0641-9218-01 00641921801 10 mL in 1 VIAL 10 ml Historical 0641-9218-10 00641921810 10 VIAL in 1 CARTON (0641-9218-10) / 10 mL in 1 VIAL (0641-9218-01) 10 vial 2008-12-17 0000-00-00 No No Current