Home NDC 0187-0792 Cardizem
Product NDC 0187-0792
11-digit product format 001870792
Labeler code 0187
Product ID 0187-0792_340462fa-5523-448e-e063-6294a90a4eab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diltiazem Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Bausch Health US LLC
Application NDA018602
Marketing category NDA
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 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 Cardizem
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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 831054 Internal RxNorm lookup 831055 Internal RxNorm lookup 831102 Internal RxNorm lookup 831103 Internal RxNorm lookup 831137 Internal RxNorm lookup 833217 Internal RxNorm lookup 833219 Internal RxNorm lookup 834393 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 0187-0792-47 Cardizem 100 in 1 BOTTLE TABLET, COATED 100 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Diltiazem Hydrochloride ACTIVE INGREDIENT OLH94387TE CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 7 Diltiazem ACTIVE MOIETY EE92BBP03H CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 7 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 7 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 7 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 7 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 7 lactose INACTIVE INGREDIENT J2B2A4N98G CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 7 magnesium stearate INACTIVE INGREDIENT 70097M6I30 CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 7 methylparaben INACTIVE INGREDIENT A2I8C7HI9T CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 7 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 7 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0187-0792 CARDIZEM (DILTIAZEM HYDROCHLORIDE) TABLET, COATED [BAUSCH HEALTH US LLC] 20 Current NDC, Legacy NDC, 1 package rows 20250502_f3e7ecef-f360-4987-a4f5-933214130ab2.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 Marketing start Marketing end Sample Exclude flag Status 0187-0792-47 00187079247 100 TABLET, COATED in 1 BOTTLE (0187-0792-47) 2010-12-25 0000-00-00 No No Current