Home NDC 68682-008 Diltiazem Hydrochloride
Product NDC 68682-008
11-digit product format 686820008
Labeler code 68682
Product ID 68682-008_06626a5d-987f-4d1c-9ffc-28fd51362900
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diltiazem Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Oceanside Pharmaceuticals
Application NDA018602
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2010-12-25
Substance DILTIAZEM HYDROCHLORIDE
Active strength 90 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 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 90 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 831054 Internal RxNorm lookup 831102 Internal RxNorm lookup 831103 Internal RxNorm lookup 833217 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 68682-008-10 Diltiazem Hydrochloride 100 in 1 BOTTLE TABLET 100 9 68682-008-50 Diltiazem Hydrochloride 500 in 1 BOTTLE TABLET 500 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68682-008 DILTIAZEM HYDROCHLORIDE TABLET DILTIAZEM HYDROCHLORIDE TABLET [OCEANSIDE PHARMACEUTICALS] 9 Current NDC, Legacy NDC, 2 package rows 20230329_f6a24de7-8ffe-48af-873f-10fdcd5551d1.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 68682-008-10 68682000810 100 TABLET in 1 BOTTLE (68682-008-10) 100 tablet 2010-12-25 0000-00-00 No No Current 68682-008-50 68682000850 500 TABLET in 1 BOTTLE (68682-008-50) 500 tablet 2010-12-25 0000-00-00 No No Current