diltiazem hydrochloride
- Product NDC
- 68788-7634
- Requested package NDC
- 68788-7634-9
- 11-digit product format
- 687887634
- Labeler code
- 68788
- Product ID
- 68788-7634_fe289d4b-c361-479a-a024-fce9b73b724b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diltiazem hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA206534
- Marketing category
- ANDA
- Marketing start
- 2020-03-06
- Marketing end
- 0000-00-00
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 120 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 package | package | 68788-7634 | 68788-7634-9 | D | Discontinued by firm | 2026-10-05 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206534-001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | |
| A206534-002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | |
| A206534-003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | |
| A206534-004 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | |
| A206534-005 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206534-001 | AB3 |
| A206534-002 | AB3 |
| A206534-003 | AB3 |
| A206534-004 | AB3 |
| A206534-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A206534-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206534-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206534-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206534-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A206534-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A206534-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206534-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206534-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206534-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206534-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206534-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206534-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206534-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206534-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206534-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206534-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206534-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206534-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206534-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206534-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206534-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206534-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206534-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206534-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206534-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206534-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206534-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206534-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206534-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206534-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206534-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206534-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206534-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206534-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206534-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206534-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206534-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206534-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206534-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206534-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2017-08-08 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A206534-001 | AB3 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A206534-002 | AB3 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A206534-003 | AB3 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A206534-004 | AB3 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A206534-005 | AB3 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A206534-001 | AB3 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206534-002 | AB3 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206534-003 | AB3 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206534-004 | AB3 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206534-005 | AB3 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206534-001 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206534-002 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206534-003 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206534-004 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206534-005 | AB3 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206534-001 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206534-002 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206534-003 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206534-004 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206534-005 | AB3 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206534-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206534-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206534-003 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206534-004 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206534-005 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206534-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206534-002 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206534-003 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206534-004 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206534-005 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206534-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206534-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206534-003 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206534-004 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206534-005 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206534-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206534-002 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206534-003 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206534-004 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206534-005 | AB3 | 1 | 03ed91905a0d… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7634-1 | EA - Each | 68788-7634 | c2149087-0763-455e-b62e-89dde70c5f63 | 1 | 2020-04-20 |
| 68788-7634-3 | EA - Each | 68788-7634 | 5d7e98dd-2e88-4a6a-823b-49b9449caa23 | 1 | 2020-04-20 |
| 68788-7634-6 | EA - Each | 68788-7634 | fcee76c4-dc9f-46d9-9bd1-4262f423ac00 | 1 | 2020-04-20 |
| 68788-7634-8 | EA - Each | 68788-7634 | d36967f6-e6e5-4cf4-8e89-90c730232b9b | 1 | 2020-04-20 |
| 68788-7634-9 | EA - Each | 68788-7634 | 991f2225-624f-4a62-8a47-45aab9bb77ce | 1 | 2020-04-20 |
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 |
|---|---|---|---|---|---|---|
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | c044f774-783f-4920-a8a1-6d4b1b3820c1 | 2025-06-11 | Warnings, Adverse reactions | 206534 ANDA206534 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | 1e2f2025-0350-40c4-ab42-3b57f3d105a6 | 2025-05-01 | Warnings, Adverse reactions | 206534 ANDA206534 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Zydus Lifesciences Limited | fe790439-85d4-4cd8-a385-149ea3442a38 | 2025-05-01 | Warnings, Adverse reactions | 206534 ANDA206534 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-7634-9 | 68788763409 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7634-9) | 2020-03-06 | 0000-00-00 | No | No | Current |