Diltiazem Hydrochloride
- Product NDC
- 70518-2451
- 11-digit product format
- 705182451
- Labeler code
- 70518
- Product ID
- 70518-2451_f19c0138-c1c6-9420-e053-2995a90a0e59
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride Extended-Release Tablets
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA021392
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2019-11-25
- Marketing end
- 0000-00-00
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 240 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2024-12-31
- 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 | 70518-2451 | D | Discontinued by firm | 2026-09-09 | ||
| excluded package | package | 70518-2451 | 70518-2451-0 | D | Discontinued by firm | 2026-09-09 | |
| excluded package | package | 70518-2451 | 70518-2451-1 | D | Discontinued by firm | 2026-09-09 | |
| excluded package | package | 70518-2451 | 70518-2451-2 | D | Discontinued by firm | 2026-09-09 |
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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-2451-0 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-2451-1 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-2451-2 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-2451-0 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-2451-1 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-2451-2 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-2451-0 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-2451-1 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-2451-2 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-2451-0 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-2451-1 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-2451-2 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-2451-0 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-2451-1 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-2451-2 | D | Discontinued by firm | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-2451-0 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-2451-1 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-2451-2 | D | Discontinued by firm | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-2451-0 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-2451-1 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-2451-2 | D | Discontinued by firm | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-2451-0 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-2451-1 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-2451-2 | D | Discontinued by firm | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-2451-1 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-2451-0 | D | Discontinued by firm | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-2451-2 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-2451-1 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-2451-0 | D | Discontinued by firm | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-2451-1 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-2451-0 | D | Discontinued by firm | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-2451-1 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-2451-0 | D | Discontinued by firm | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021392-001 | CARDIZEM LA | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 |
| N021392-002 | CARDIZEM LA | DILTIAZEM HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 |
| N021392-003 | CARDIZEM LA | DILTIAZEM HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 |
| N021392-004 | CARDIZEM LA | DILTIAZEM HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 |
| N021392-005 | CARDIZEM LA | DILTIAZEM HYDROCHLORIDE | 360MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 |
| N021392-006 | CARDIZEM LA | DILTIAZEM HYDROCHLORIDE | 420MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2003-02-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021392-001 | AB |
| N021392-002 | AB |
| N021392-003 | AB |
| N021392-004 | AB |
| N021392-005 | AB |
| N021392-006 | 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 | N021392-001 | CARDIZEM LA | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021392-002 | CARDIZEM LA | 180MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021392-003 | CARDIZEM LA | 240MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021392-004 | CARDIZEM LA | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021392-005 | CARDIZEM LA | 360MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021392-006 | CARDIZEM LA | 420MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2003-02-06 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021392-001 | CARDIZEM LA | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021392-002 | CARDIZEM LA | 180MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021392-003 | CARDIZEM LA | 240MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021392-004 | CARDIZEM LA | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021392-005 | CARDIZEM LA | 360MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021392-006 | CARDIZEM LA | 420MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2003-02-06 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021392-001 | CARDIZEM LA | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021392-002 | CARDIZEM LA | 180MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021392-003 | CARDIZEM LA | 240MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021392-004 | CARDIZEM LA | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021392-005 | CARDIZEM LA | 360MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021392-006 | CARDIZEM LA | 420MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2003-02-06 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021392-001 | CARDIZEM LA | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021392-002 | CARDIZEM LA | 180MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021392-003 | CARDIZEM LA | 240MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021392-004 | CARDIZEM LA | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021392-005 | CARDIZEM LA | 360MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021392-006 | CARDIZEM LA | 420MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2003-02-06 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021392-001 | CARDIZEM LA | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021392-002 | CARDIZEM LA | 180MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021392-003 | CARDIZEM LA | 240MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021392-004 | CARDIZEM LA | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021392-005 | CARDIZEM LA | 360MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021392-006 | CARDIZEM LA | 420MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2003-02-06 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021392-001 | CARDIZEM LA | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021392-002 | CARDIZEM LA | 180MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021392-003 | CARDIZEM LA | 240MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021392-004 | CARDIZEM LA | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021392-005 | CARDIZEM LA | 360MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021392-006 | CARDIZEM LA | 420MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2003-02-06 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021392-001 | CARDIZEM LA | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021392-002 | CARDIZEM LA | 180MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021392-003 | CARDIZEM LA | 240MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021392-004 | CARDIZEM LA | 300MG | TABLET, EXTENDED RELEASE / ORAL | AB | RLD | 2003-02-06 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N021392-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021392-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021392-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021392-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021392-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021392-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021392-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021392-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021392-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021392-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021392-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021392-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021392-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021392-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021392-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021392-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021392-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021392-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021392-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021392-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021392-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021392-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021392-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021392-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021392-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021392-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021392-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021392-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021392-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021392-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021392-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021392-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021392-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021392-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021392-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021392-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021392-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021392-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021392-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021392-004 | AB | 1 | 03ed91905a0d… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021392-001 | 7108866 | 2019-12-17 | U-107 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021392-001 | 6923984 | 2021-02-25 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021392-002 | 7108866 | 2019-12-17 | U-107 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021392-002 | 6923984 | 2021-02-25 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021392-003 | 7108866 | 2019-12-17 | U-107 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021392-003 | 6923984 | 2021-02-25 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021392-004 | 7108866 | 2019-12-17 | U-107 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021392-004 | 6923984 | 2021-02-25 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021392-005 | 7108866 | 2019-12-17 | U-107 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021392-005 | 6923984 | 2021-02-25 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021392-006 | 7108866 | 2019-12-17 | U-107 | Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021392-006 | 6923984 | 2021-02-25 | Drug product | 74a2ff9319b5… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021392-001 | 6923984 | 2021-02-25 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021392-002 | 6923984 | 2021-02-25 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021392-003 | 6923984 | 2021-02-25 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021392-004 | 6923984 | 2021-02-25 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021392-005 | 6923984 | 2021-02-25 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021392-006 | 6923984 | 2021-02-25 | Drug product | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021392-001 | 6923984 | 2021-02-25 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021392-002 | 6923984 | 2021-02-25 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021392-003 | 6923984 | 2021-02-25 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021392-004 | 6923984 | 2021-02-25 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021392-005 | 6923984 | 2021-02-25 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021392-006 | 6923984 | 2021-02-25 | Drug product | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021392-001 | 6923984 | 2021-02-25 | Drug product | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021392-002 | 6923984 | 2021-02-25 | Drug product | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021392-003 | 6923984 | 2021-02-25 | Drug product | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021392-004 | 6923984 | 2021-02-25 | Drug product | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021392-005 | 6923984 | 2021-02-25 | Drug product | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021392-006 | 6923984 | 2021-02-25 | Drug product | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021392-001 | 6923984 | 2021-02-25 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021392-002 | 6923984 | 2021-02-25 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021392-003 | 6923984 | 2021-02-25 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021392-004 | 6923984 | 2021-02-25 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021392-005 | 6923984 | 2021-02-25 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021392-006 | 6923984 | 2021-02-25 | Drug product | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021392-001 | 6923984 | 2021-02-25 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021392-002 | 6923984 | 2021-02-25 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021392-003 | 6923984 | 2021-02-25 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021392-004 | 6923984 | 2021-02-25 | Drug product | c0c555d07b60… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70518-2451-0 | EA - Each | 70518-2451 | 6b672434-fe1c-426e-9cb6-448b587a3300 | 1 | 2024-04-05 |
| 70518-2451-2 | EA - Each | 70518-2451 | 6f3c4973-42ed-4995-b270-42a27d9be8e1 | 1 | 2024-04-05 |
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 LA | DILTIAZEM HYDROCHLORIDE | Bausch Health US LLC | 3e180dc7-c871-4efc-8755-cae882976c8d | 2025-11-11 | Warnings, Adverse reactions | 021392 NDA021392 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS | Oceanside Pharmaceuticals | 73b3607a-99d0-44d8-92ef-0074684c9d7d | 2025-04-01 | Warnings, Adverse reactions | 021392 NDA021392 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-2451-0 | 70518245100 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2451-0) | 2019-11-25 | 0000-00-00 | No | No | Current |
| 70518-2451-2 | 70518245102 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2451-2) | 2022-01-04 | 0000-00-00 | No | No | Current |