Home NDC 68382-562-05 Verapamil hydrochloride
Product NDC 68382-562
Requested package NDC 68382-562-05
11-digit product format 683820562
Labeler code 68382
Product ID 68382-562_ffca6bb5-e52a-426d-8f93-5e0e8da34eed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Verapamil hydrochloride
Dosage form TABLET
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA219252
Marketing category ANDA
Marketing start 2026-05-21
Substance VERAPAMIL HYDROCHLORIDE
Active strength 180 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219252-001 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-24 A219252-002 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-24 A219252-003 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-24
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 2026-02-19 14:30 UTC 2026-02 A219252-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219252-002 VERAPAMIL HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219252-003 VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219252-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219252-002 VERAPAMIL HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219252-003 VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-24 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219252-001 VERAPAMIL HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219252-002 VERAPAMIL HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219252-003 VERAPAMIL HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2025-11-24 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Verapamil hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VERAPAMIL 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 V3888OEY5R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 897640 Internal RxNorm lookup 897649 Internal RxNorm lookup 897659 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 68382-562-01 Verapamil hydrochloride 100 in 1 BOTTLE TABLET 100 1 68382-562-05 Verapamil hydrochloride 500 in 1 BOTTLE TABLET 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 Units Marketing start Sample Exclude flag Status 68382-562-05 68382056205 500 TABLET in 1 BOTTLE (68382-562-05) 500 tablet 2026-05-21 No No Current