Home NDC 0615-3548 Diltiazem Hydrochloride
Product NDC 0615-3548
11-digit product format 006153548
Labeler code 0615
Product ID 0615-3548_65056a10-2b8a-422d-9c01-daf103203ed2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diltiazem Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA072838
Marketing category ANDA
Marketing start 2012-12-04
Marketing end 0000-00-00
Substance DILTIAZEM HYDROCHLORIDE
Active strength 30 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 45 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-3548-39 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0615-3548-31 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-3548-39 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0615-3548-31 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-3548-39 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0615-3548-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-3548-39 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0615-3548-31 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-3548-39 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0615-3548-31 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-3548-39 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0615-3548-31 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-3548-39 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0615-3548-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-3548-39 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0615-3548-31 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-3548-39 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0615-3548-31 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-3548-39 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0615-3548-31 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-3548-39 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0615-3548-31 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-3548-39 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0615-3548-31 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-3548-31 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0615-3548-39 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-3548-31 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0615-3548-39 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-3548-39 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0615-3548-31 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A072838-001 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL 1992-11-05 A072838-002 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL 1992-11-05 A072838-003 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL 1992-11-05 A072838-004 DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL 1992-11-05
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 5 · 172 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 2026-09-14 22:38:34 2026-08 A072838-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL 1992-11-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A072838-002 DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL 1992-11-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A072838-003 DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL 1992-11-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A072838-004 DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL 1992-11-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072838-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL 1992-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072838-002 DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL 1992-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072838-003 DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL 1992-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072838-004 DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL 1992-11-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072838-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL 1992-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072838-002 DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL 1992-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072838-003 DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL 1992-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072838-004 DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL 1992-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072838-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL 1992-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072838-002 DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL 1992-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072838-003 DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL 1992-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072838-004 DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL 1992-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072838-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL 1992-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072838-002 DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL 1992-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072838-003 DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL 1992-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072838-004 DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL 1992-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072838-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL 1992-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072838-002 DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL 1992-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072838-003 DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL 1992-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072838-004 DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL 1992-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072838-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL 1992-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072838-002 DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL 1992-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072838-003 DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL 1992-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072838-004 DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL 1992-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072838-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL 1992-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072838-002 DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL 1992-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072838-003 DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL 1992-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072838-004 DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL 1992-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072838-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL 1992-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072838-002 DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL 1992-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072838-003 DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL 1992-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072838-004 DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL 1992-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072838-001 DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL 1992-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072838-002 DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL 1992-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072838-003 DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL 1992-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072838-004 DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL 1992-11-05 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0615-3548-31 2021-04-27 DILTIAZEM HYDROCHLORIDE TABLETS, USP 30 mg, 60 mg, 90 mg and 120 mg 0615-3548-39 2021-04-27 DILTIAZEM HYDROCHLORIDE TABLETS, USP 30 mg, 60 mg, 90 mg and 120 mg 0615-3548-31 2020-01-31 DILTIAZEM HYDROCHLORIDE TABLETS, USP 30 mg, 60 mg, 90 mg and 120 mg 0615-3548-39 2020-01-31 DILTIAZEM HYDROCHLORIDE TABLETS, USP 30 mg, 60 mg, 90 mg and 120 mg
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DILTIAZEM HYDROCHLORIDE ACTIVE INGREDIENT OLH94387TE DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 DILTIAZEM ACTIVE MOIETY EE92BBP03H DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10