Diltiazem HCl CD
- Product NDC
- 71335-2029
- 11-digit product format
- 713352029
- Labeler code
- 71335
- Product ID
- 71335-2029_fb70027d-afde-4a0b-b0ae-2fa48b48229f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- CAPSULE, COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- NDA020062
- Marketing category
- NDA
- Marketing start
- 2001-04-11
- Marketing end
- 0000-00-00
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 360 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 71335-2029 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 71335-2029 | 71335-2029-1 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 71335-2029 | 71335-2029-2 | D | Discontinued by firm | 2026-08-11 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020062-001 | CARDIZEM CD | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1992-08-10 |
| N020062-002 | CARDIZEM CD | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 |
| N020062-003 | CARDIZEM CD | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 |
| N020062-004 | CARDIZEM CD | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 |
| N020062-005 | CARDIZEM CD | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 1999-08-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020062-001 | AB3 |
| N020062-002 | AB3 |
| N020062-003 | AB3 |
| N020062-004 | AB3 |
| N020062-005 | AB3 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020062-001 | CARDIZEM CD | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1992-08-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020062-002 | CARDIZEM CD | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020062-003 | CARDIZEM CD | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020062-004 | CARDIZEM CD | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020062-005 | CARDIZEM CD | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 1999-08-24 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020062-001 | CARDIZEM CD | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1992-08-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020062-002 | CARDIZEM CD | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020062-003 | CARDIZEM CD | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020062-004 | CARDIZEM CD | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020062-005 | CARDIZEM CD | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 1999-08-24 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020062-001 | CARDIZEM CD | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1992-08-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020062-002 | CARDIZEM CD | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020062-003 | CARDIZEM CD | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020062-004 | CARDIZEM CD | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020062-005 | CARDIZEM CD | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 1999-08-24 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020062-001 | CARDIZEM CD | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1992-08-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020062-002 | CARDIZEM CD | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020062-003 | CARDIZEM CD | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020062-004 | CARDIZEM CD | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020062-005 | CARDIZEM CD | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 1999-08-24 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020062-001 | CARDIZEM CD | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1992-08-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020062-002 | CARDIZEM CD | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020062-003 | CARDIZEM CD | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020062-004 | CARDIZEM CD | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020062-005 | CARDIZEM CD | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 1999-08-24 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020062-001 | CARDIZEM CD | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1992-08-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020062-002 | CARDIZEM CD | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020062-003 | CARDIZEM CD | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020062-004 | CARDIZEM CD | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020062-005 | CARDIZEM CD | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 1999-08-24 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020062-001 | CARDIZEM CD | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1992-08-10 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020062-002 | CARDIZEM CD | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020062-003 | CARDIZEM CD | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020062-004 | CARDIZEM CD | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020062-005 | CARDIZEM CD | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 1999-08-24 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020062-001 | CARDIZEM CD | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1992-08-10 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020062-002 | CARDIZEM CD | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020062-003 | CARDIZEM CD | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020062-004 | CARDIZEM CD | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD | 1991-12-27 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020062-005 | CARDIZEM CD | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | RLD, RS | 1999-08-24 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020062-001 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020062-002 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020062-003 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020062-004 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020062-005 | AB3 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020062-001 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020062-002 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020062-003 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020062-004 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020062-005 | AB3 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020062-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020062-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020062-003 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020062-004 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020062-005 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020062-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020062-002 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020062-003 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020062-004 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020062-005 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020062-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020062-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020062-003 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020062-004 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020062-005 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020062-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020062-002 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020062-003 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020062-004 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020062-005 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020062-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020062-002 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020062-003 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020062-004 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020062-005 | AB3 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020062-001 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020062-002 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020062-003 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020062-004 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020062-005 | AB3 | 1 | 5bbf6a4d5a75… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71335-2029-1 | EA - Each | 71335-2029 | be24b36f-f668-4d07-9f6e-a9790021ddc3 | 1 | 2025-07-08 |
| 71335-2029-2 | EA - Each | 71335-2029 | d8d2bcba-8d16-4c8c-baec-2ef9e575c504 | 1 | 2025-07-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-2029 | DILTIAZEM HCL CD (DILTIAZEM HYDROCHLORIDE) CAPSULE, COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 101 | Legacy NDC | 20230609_eef5dc85-5319-4f7e-bc59-659a5c8a95ee.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cardizem CD | DILTIAZEM HYDROCHLORIDE | Bausch Health US LLC | 1042fa13-e6af-46b9-8008-6c941f0978b1 | 2025-12-10 | Warnings, Adverse reactions | 020062 NDA020062 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71335-2029-1 | 71335202901 | 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2029-1) | 2022-02-24 | 0000-00-00 | No | No | Current |
| 71335-2029-2 | 71335202902 | 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2029-2) | 2022-02-24 | 0000-00-00 | No | No | Current |