Home NDC 70518-2270 Matzim LA
Product NDC 70518-2270
11-digit product format 705182270
Labeler code 70518
Product ID 70518-2270_90822612-4c77-06fc-e053-2995a90ac677
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diltiazem Hydrochloride
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA077686
Marketing category ANDA
Marketing start 2019-08-19
Marketing end 0000-00-00
Substance DILTIAZEM HYDROCHLORIDE
Active strength 240 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-2270-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-2270-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70518-2270-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70518-2270-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70518-2270-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70518-2270-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70518-2270-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70518-2270-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70518-2270-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70518-2270-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70518-2270-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70518-2270-0 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077686-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 A077686-002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 A077686-003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 A077686-004 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 A077686-005 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 A077686-006 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 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.
Product history page 1 of 7 · 264 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 A077686-001 DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077686-002 DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077686-003 DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077686-004 DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077686-005 DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077686-006 DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077686-001 DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077686-002 DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077686-003 DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077686-004 DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077686-005 DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077686-006 DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077686-001 DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077686-002 DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077686-003 DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077686-004 DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077686-005 DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077686-006 DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077686-001 DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077686-002 DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077686-003 DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077686-004 DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077686-005 DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077686-006 DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077686-001 DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077686-002 DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077686-003 DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077686-004 DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077686-005 DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077686-006 DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077686-001 DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077686-002 DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077686-003 DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077686-004 DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077686-005 DILTIAZEM HYDROCHLORIDE 180MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077686-006 DILTIAZEM HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077686-001 DILTIAZEM HYDROCHLORIDE 420MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077686-002 DILTIAZEM HYDROCHLORIDE 360MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077686-003 DILTIAZEM HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077686-004 DILTIAZEM HYDROCHLORIDE 240MG TABLET, EXTENDED RELEASE / ORAL AB 2010-03-15 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 7 · 264 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.