Home NDC 44567-662 DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE
Product NDC 44567-662
11-digit product format 445670662
Labeler code 44567
Product ID 44567-662_d3c2dae2-c1e5-469e-ad68-46fe6712d2c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diltiazem Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler WG Critical Care, LLC
Application NDA218038
Marketing category NDA
Marketing start 2025-03-21
Substance DILTIAZEM HYDROCHLORIDE
Active strength 1 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218038-001 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE DILTIAZEM HYDROCHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 N218038-002 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE DILTIAZEM HYDROCHLORIDE 250MG/250ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21
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.
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 N218038-001 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218038-002 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE 250MG/250ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218038-001 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218038-002 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE 250MG/250ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218038-001 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218038-002 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE 250MG/250ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218038-001 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218038-002 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE 250MG/250ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218038-001 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218038-002 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE 250MG/250ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DILTIAZEM HYDROCHLORIDE 1 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2586036 Internal RxNorm lookup 2709225 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 44567-662-01 DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE 100 mL in 1 BAG INJECTION, SOLUTION 100 3 44567-662-10 DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE 10 in 1 CARTON INJECTION, SOLUTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44567-662 DILTIAZEM HYDROCHLORIDE IN SODIUM CHLORIDE (DILTIAZEM HYDROCHLORIDE) INJECTION, SOLUTION [WG CRITICAL CARE, LLC] 3 Current NDC, 2 package rows 20250417_8bae87a5-2137-467e-a1ad-79b2bc075e07.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 Sample Exclude flag Status 44567-662-01 44567066201 100 mL in 1 BAG 100 ml Historical 44567-662-10 44567066210 10 BAG in 1 CARTON (44567-662-10) / 100 mL in 1 BAG (44567-662-01) 10 bag 2025-03-21 No No Current