Home NDC 46708-781 Diltiazem Hydrochloride
Product NDC 46708-781
11-digit product format 467080781
Labeler code 46708
Product ID 46708-781_74bab197-f719-48c0-ac84-c0cf0087b45a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diltiazem Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA217633
Marketing category ANDA
Marketing start 2025-11-14
Substance DILTIAZEM HYDROCHLORIDE
Active strength 30 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 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217633-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL AB 2025-11-14 A217633-002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL AB 2025-11-14 A217633-003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL AB 2025-11-14 A217633-004 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL AB 2025-11-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 2026-02-19 14:30 UTC 2026-02 A217633-001 DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL AB 2025-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217633-002 DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL AB 2025-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217633-003 DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL AB 2025-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217633-004 DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL AB 2025-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217633-001 DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL AB 2025-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217633-002 DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL AB 2025-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217633-003 DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL AB 2025-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217633-004 DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL AB 2025-11-14 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217633-001 DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL AB 2025-11-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217633-002 DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL AB 2025-11-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217633-003 DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL AB 2025-11-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217633-004 DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL AB 2025-11-14 a50c72e98297…
Observed Orange Book normalized TE history# 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 30 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 831054 Internal RxNorm lookup 831102 Internal RxNorm lookup 831103 Internal RxNorm lookup 833217 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 46708-781-31 Diltiazem Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 1 46708-781-71 Diltiazem Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 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 · 2 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 46708-781-31 46708078131 100 TABLET, FILM COATED in 1 BOTTLE (46708-781-31) 2025-11-14 No No Current 46708-781-71 46708078171 500 TABLET, FILM COATED in 1 BOTTLE (46708-781-71) 2025-11-14 No No Current