Home NDC 68071-4242-3 Diltiazem Hydrochloride
Product NDC 68071-4242
Requested package NDC 68071-4242-3
11-digit product format 680714242
Labeler code 68071
Product ID 68071-4242_1a3c5c49-b375-1318-e063-6394a90a47b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diltiazem Hydrochloride
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application NDA018602
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2010-12-25
Substance DILTIAZEM HYDROCHLORIDE
Active strength 120 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 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 2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4242 68071-4242-3 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4242 68071-4242-3 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4242 68071-4242-3 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 N018602-001 CARDIZEM DILTIAZEM HYDROCHLORIDE 30MG TABLET / ORAL AB RLD 1982-11-05 N018602-002 CARDIZEM DILTIAZEM HYDROCHLORIDE 60MG TABLET / ORAL AB RLD 1982-11-05 N018602-003 CARDIZEM DILTIAZEM HYDROCHLORIDE 90MG TABLET / ORAL AB RLD 1986-12-08 N018602-004 CARDIZEM DILTIAZEM HYDROCHLORIDE 120MG TABLET / ORAL AB RLD, RS 1986-12-08
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.
Product history page 1 of 5 · 164 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 2026-02-19 14:30 UTC 2026-02 N018602-001 CARDIZEM 30MG TABLET / ORAL AB RLD 1982-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018602-002 CARDIZEM 60MG TABLET / ORAL AB RLD 1982-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018602-003 CARDIZEM 90MG TABLET / ORAL AB RLD 1986-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018602-004 CARDIZEM 120MG TABLET / ORAL AB RLD, RS 1986-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018602-001 CARDIZEM 30MG TABLET / ORAL AB RLD 1982-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018602-002 CARDIZEM 60MG TABLET / ORAL AB RLD 1982-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018602-003 CARDIZEM 90MG TABLET / ORAL AB RLD 1986-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018602-004 CARDIZEM 120MG TABLET / ORAL AB RLD, RS 1986-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018602-001 CARDIZEM 30MG TABLET / ORAL AB RLD 1982-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018602-002 CARDIZEM 60MG TABLET / ORAL AB RLD 1982-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018602-003 CARDIZEM 90MG TABLET / ORAL AB RLD 1986-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018602-004 CARDIZEM 120MG TABLET / ORAL AB RLD, RS 1986-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018602-001 CARDIZEM 30MG TABLET / ORAL AB RLD 1982-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018602-002 CARDIZEM 60MG TABLET / ORAL AB RLD 1982-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018602-003 CARDIZEM 90MG TABLET / ORAL AB RLD 1986-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018602-004 CARDIZEM 120MG TABLET / ORAL AB RLD, RS 1986-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018602-001 CARDIZEM 30MG TABLET / ORAL AB RLD 1982-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018602-002 CARDIZEM 60MG TABLET / ORAL AB RLD 1982-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018602-003 CARDIZEM 90MG TABLET / ORAL AB RLD 1986-12-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018602-004 CARDIZEM 120MG TABLET / ORAL AB RLD, RS 1986-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018602-001 CARDIZEM 30MG TABLET / ORAL AB RLD 1982-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018602-002 CARDIZEM 60MG TABLET / ORAL AB RLD 1982-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018602-003 CARDIZEM 90MG TABLET / ORAL AB RLD 1986-12-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018602-004 CARDIZEM 120MG TABLET / ORAL AB RLD, RS 1986-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018602-001 CARDIZEM 30MG TABLET / ORAL AB RLD 1982-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018602-002 CARDIZEM 60MG TABLET / ORAL AB RLD 1982-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018602-003 CARDIZEM 90MG TABLET / ORAL AB RLD 1986-12-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018602-004 CARDIZEM 120MG TABLET / ORAL AB RLD, RS 1986-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018602-001 CARDIZEM 30MG TABLET / ORAL AB RLD 1982-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018602-002 CARDIZEM 60MG TABLET / ORAL AB RLD 1982-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018602-003 CARDIZEM 90MG TABLET / ORAL AB RLD 1986-12-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018602-004 CARDIZEM 120MG TABLET / ORAL AB RLD, RS 1986-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018602-001 CARDIZEM 30MG TABLET / ORAL AB RLD 1982-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018602-002 CARDIZEM 60MG TABLET / ORAL AB RLD 1982-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018602-003 CARDIZEM 90MG TABLET / ORAL AB RLD 1986-12-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018602-004 CARDIZEM 120MG TABLET / ORAL AB RLD, RS 1986-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018602-001 CARDIZEM 30MG TABLET / ORAL AB RLD 1982-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018602-002 CARDIZEM 60MG TABLET / ORAL AB RLD 1982-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018602-003 CARDIZEM 90MG TABLET / ORAL AB RLD 1986-12-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018602-004 CARDIZEM 120MG TABLET / ORAL AB RLD, RS 1986-12-08 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
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 120 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 831054 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4242-3 Diltiazem Hydrochloride 30 in 1 BOTTLE TABLET 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4242 DILTIAZEM HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.] 5 Current NDC, Legacy NDC, 1 package rows 20240608_636556f6-2987-984f-e053-2991aa0a201a.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-4242-3 68071424203 30 TABLET in 1 BOTTLE (68071-4242-3) 30 tablet 2018-01-22 0000-00-00 No No Current