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_d0053944-61f6-461d-8ea7-caac7b6c3e70
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 2026-09-14 22:38:34 2026-08 N218038-001 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218038-002 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE 250MG/250ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218038-001 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE 100MG/100ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218038-002 DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE 250MG/250ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-21 caaa826d4ba7…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base DILTIAZEM HYDROCHLORIDE in SODIUM CHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DILTIAZEM HYDROCHLORIDE 1 mg/mL
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
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