Home NDC 50090-6146 Diltiazem hydrochloride
Product NDC 50090-6146
11-digit product format 500906146
Labeler code 50090
Product ID 50090-6146_9a4f3652-7294-456e-8bb1-e4360e6c8380
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diltiazem hydrochloride
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA203023
Marketing category ANDA
Marketing start 2018-10-31
Marketing end 0000-00-00
Substance DILTIAZEM HYDROCHLORIDE
Active strength 180 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 50090-6146 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-6146 50090-6146-0 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-6146 50090-6146-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A203023-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 A203023-002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 A203023-003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 A203023-004 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 A203023-005 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203023-005 AB3
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.
Product history page 1 of 6 · 220 observed 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 2026-10-15 13:18:30 2026-09 A203023-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203023-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203023-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203023-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203023-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203023-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203023-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203023-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203023-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203023-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203023-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203023-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203023-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203023-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203023-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203023-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203023-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203023-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203023-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203023-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203023-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203023-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203023-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203023-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203023-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203023-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203023-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203023-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203023-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203023-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203023-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203023-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203023-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203023-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL 2017-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203023-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203023-001 DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203023-002 DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203023-003 DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203023-004 DILTIAZEM HYDROCHLORIDE 300MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203023-005 DILTIAZEM HYDROCHLORIDE 360MG CAPSULE, EXTENDED RELEASE / ORAL AB3 2017-06-08 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 191 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-6146 DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] 3 Legacy NDC 20231102_7509a935-2d82-44d2-b93e-06ea6d780df9.zip
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-6146-0 50090614600 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-6146-0) 2022-10-04 0000-00-00 No No Current 50090-6146-1 50090614601 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-6146-1) 2022-10-04 0000-00-00 No No Current