Home NDC 33342-522 Diltiazem Hydrochloride
Product NDC 33342-522
11-digit product format 333420522
Labeler code 33342
Product ID 33342-522_850566b1-0c8e-42bc-85fa-c8ee710f34ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diltiazem Hydrochloride
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA218744
Marketing category ANDA
Marketing start 2023-06-23
Substance DILTIAZEM HYDROCHLORIDE
Active strength 180 mg/1
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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218744-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2026-02-27 A218744-002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2026-02-27 A218744-003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2026-02-27 A218744-004 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2026-02-27 A218744-005 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2026-02-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218744-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2026-02-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218744-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2026-02-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218744-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2026-02-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218744-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2026-02-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218744-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2026-02-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218744-001 AB3 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218744-002 AB3 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218744-003 AB3 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218744-004 AB3 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218744-005 AB3 1 a50c72e98297…
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 180 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 830795 Internal RxNorm lookup 830801 Internal RxNorm lookup 830837 Internal RxNorm lookup 830845 Internal RxNorm lookup 830861 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 33342-522-02 Diltiazem Hydrochloride 6 in 1 BLISTER PACK CAPSULE, EXTENDED RELEASE 6 1 33342-522-07 Diltiazem Hydrochloride 30 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 30 1 33342-522-10 Diltiazem Hydrochloride 90 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 90 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 33342-522-02 33342052202 6 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (33342-522-02) 2023-06-23 No No Current 33342-522-07 33342052207 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-522-07) 2023-06-23 No No Current 33342-522-10 33342052210 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-522-10) 2023-06-23 No No Current