Cardizem
- Product NDC
- 0187-0772
- Requested package NDC
- 0187-0772-47
- 11-digit product format
- 001870772
- Labeler code
- 0187
- Product ID
- 0187-0772_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
- 60 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
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| N018602-001 | AB |
| N018602-002 | AB |
| N018602-003 | AB |
| N018602-004 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N018602-001 | CARDIZEM | 30MG | TABLET / ORAL | AB | RLD | 1982-11-05 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018602-002 | CARDIZEM | 60MG | TABLET / ORAL | AB | RLD | 1982-11-05 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018602-003 | CARDIZEM | 90MG | TABLET / ORAL | AB | RLD | 1986-12-08 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018602-004 | CARDIZEM | 120MG | TABLET / ORAL | AB | RLD, RS | 1986-12-08 | caaa826d4ba7… |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N018602-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018602-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018602-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N018602-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N018602-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018602-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018602-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018602-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018602-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018602-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018602-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018602-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018602-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018602-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018602-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018602-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018602-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018602-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018602-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018602-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018602-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018602-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018602-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018602-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018602-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018602-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018602-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018602-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018602-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018602-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018602-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018602-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018602-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018602-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018602-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018602-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018602-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018602-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018602-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018602-004 | AB | 1 | d8e5a09893c0… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cardizem
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DILTIAZEM HYDROCHLORIDE | 60 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| OLH94387TE | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f3e7ecef-f360-4987-a4f5-933214130ab2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 61ebbccf-eedf-453b-940e-dba67b7a5fef | Product name | 4 | 20260107 |
| a8d6eaa3-afcc-47e5-be12-0c9251fc8740 | Product name | 1 | 20251124 |
| f6700316-a6ba-5e59-3413-8ede05ae58b9 | Product name | 7 | 20250625 |
| 8615f7a1-1e8f-8281-8601-d7a637926d1f | Product name | 4 | 20250522 |
| 3a9daa2f-bcd1-13de-a1b4-6172caa7f308 | Product name | 2 | 20240419 |
| f7129636-cba8-86c2-8bfb-9e2e2a9c7628 | Product name | 2 | 20240314 |
| 378290be-e30f-0e68-1201-165e93c337e8 | Product name | 3 | 20231212 |
| c733b56e-b0b5-4495-9857-0256a8242279 | Product name | 1 | 20220520 |
| f4df4721-60d9-7fd2-a665-5c3c9f55af81 | Product name | 2 | 20171003 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0187-0772-47 | Cardizem | 100 in 1 BOTTLE | TABLET, COATED | 100 | 20 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0187-0772-47 | EA - Each | 0187-0772 | c399d9c0-28cf-4415-b683-e817f5fd1566 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cardizem | DILTIAZEM HYDROCHLORIDE | Bausch Health US LLC | f3e7ecef-f360-4987-a4f5-933214130ab2 | 2025-04-30 | Warnings, Adverse reactions | 018602 NDA018602 0187-0772-47 0187-0772 00187077247 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 636556f6-2987-984f-e053-2991aa0a201a | 2024-06-06 | Warnings, Adverse reactions | 018602 NDA018602 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 225a87fb-d353-4ee7-bd08-14d631ff6b16 | 2023-06-07 | Warnings, Adverse reactions | 018602 NDA018602 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Oceanside Pharmaceuticals | f6a24de7-8ffe-48af-873f-10fdcd5551d1 | 2020-06-02 | Warnings, Adverse reactions | 018602 NDA018602 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 831055 | Cardizem 120 MG Oral Tablet | PSN | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 833219 | Cardizem 30 MG Oral Tablet | PSN | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 834393 | Cardizem 60 MG Oral Tablet | PSN | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 831137 | Cardizem 90 MG Oral Tablet | PSN | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 831102 | dilTIAZem HCl 90 MG Oral Tablet | PSN | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 831054 | dilTIAZem hydrochloride 120 MG Oral Tablet | PSN | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 833217 | dilTIAZem hydrochloride 30 MG Oral Tablet | PSN | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 831103 | dilTIAZem hydrochloride 60 MG Oral Tablet | PSN | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 831055 | diltiazem hydrochloride 120 MG Oral Tablet [Cardizem] | SBD | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 833219 | diltiazem hydrochloride 30 MG Oral Tablet [Cardizem] | SBD | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 834393 | diltiazem hydrochloride 60 MG Oral Tablet [Cardizem] | SBD | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 831137 | diltiazem hydrochloride 90 MG Oral Tablet [Cardizem] | SBD | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 831054 | diltiazem hydrochloride 120 MG Oral Tablet | SCD | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 833217 | diltiazem hydrochloride 30 MG Oral Tablet | SCD | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 831103 | diltiazem hydrochloride 60 MG Oral Tablet | SCD | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 831102 | diltiazem hydrochloride 90 MG Oral Tablet | SCD | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 831055 | Cardizem 120 MG Oral Tablet | SY | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 833219 | Cardizem 30 MG Oral Tablet | SY | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 834393 | Cardizem 60 MG Oral Tablet | SY | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
| 831137 | Cardizem 90 MG Oral Tablet | SY | f3e7ecef-f360-4987-a4f5-933214130ab2 | 20 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0187-0772-47 | 00187077247 | 100 TABLET, COATED in 1 BOTTLE (0187-0772-47) | 2010-12-25 | 0000-00-00 | No | No | Current |