Home NDC 50742-564-01 Diltiazem Hydrochloride
Product NDC 50742-564
Requested package NDC 50742-564-01
11-digit product format 507420564
Labeler code 50742
Product ID 50742-564_3dd3b71c-60fb-45a2-866e-7761f1c48aa3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diltiazem hydrochloride
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA218032
Marketing category ANDA
Marketing start 2025-07-03
Substance DILTIAZEM HYDROCHLORIDE
Active strength 60 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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218032-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 A218032-002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 A218032-003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 A218032-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218032-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218032-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218032-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218032-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218032-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218032-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218032-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218032-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218032-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218032-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218032-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218032-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218032-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218032-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218032-001 DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218032-002 DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218032-003 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB1 2025-07-02 a50c72e98297…
Observed Orange Book normalized TE history# 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DILTIAZEM HYDROCHLORIDE 60 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 830865 Internal RxNorm lookup 830869 Internal RxNorm lookup 830872 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 50742-564-01 Diltiazem Hydrochloride 100 in 1 BOTTLE, PLASTIC CAPSULE, EXTENDED RELEASE 100 1 50742-564-05 Diltiazem Hydrochloride 500 in 1 BOTTLE, PLASTIC CAPSULE, EXTENDED RELEASE 500 1
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 Marketing start Sample Exclude flag Status 50742-564-01 50742056401 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-564-01) 2025-07-03 No No Current