Clarithromycin
- Product NDC
- 68788-6936
- 11-digit product format
- 687886936
- Labeler code
- 68788
- Product ID
- 68788-6936_905e8253-7639-4a30-8677-ba3496505eae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clarithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA065489
- Marketing category
- ANDA
- Marketing start
- 2017-03-27
- Marketing end
- 0000-00-00
- Substance
- CLARITHROMYCIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68788-6936 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 68788-6936 | 68788-6936-1 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-6936 | 68788-6936-2 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-6936 | 68788-6936-3 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 68788-6936 | 68788-6936-8 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | 68788-6936 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | ||
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-6936 | 68788-6936-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-6936 | 68788-6936-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-6936 | 68788-6936-8 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68788-6936 | 68788-6936-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | 68788-6936 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | ||
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-6936 | 68788-6936-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-6936 | 68788-6936-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-6936 | 68788-6936-8 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68788-6936 | 68788-6936-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 68788-6936 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | ||
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-6936 | 68788-6936-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-6936 | 68788-6936-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-6936 | 68788-6936-8 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 68788-6936 | 68788-6936-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | 68788-6936 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | ||
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-6936 | 68788-6936-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-6936 | 68788-6936-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-6936 | 68788-6936-8 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 68788-6936 | 68788-6936-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | 68788-6936 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | ||
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-6936 | 68788-6936-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-6936 | 68788-6936-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-6936 | 68788-6936-8 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 68788-6936 | 68788-6936-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | 68788-6936 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | ||
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-6936 | 68788-6936-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-6936 | 68788-6936-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-6936 | 68788-6936-8 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 68788-6936 | 68788-6936-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 68788-6936 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | ||
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-6936 | 68788-6936-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-6936 | 68788-6936-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-6936 | 68788-6936-8 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 68788-6936 | 68788-6936-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | 68788-6936 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | ||
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-6936 | 68788-6936-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-6936 | 68788-6936-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-6936 | 68788-6936-8 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 68788-6936 | 68788-6936-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 68788-6936 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | ||
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-6936 | 68788-6936-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-6936 | 68788-6936-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-6936 | 68788-6936-8 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 68788-6936 | 68788-6936-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | 68788-6936 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | ||
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-6936 | 68788-6936-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-6936 | 68788-6936-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-6936 | 68788-6936-8 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 68788-6936 | 68788-6936-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 68788-6936 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | ||
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-6936 | 68788-6936-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-6936 | 68788-6936-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-6936 | 68788-6936-8 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 68788-6936 | 68788-6936-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 68788-6936 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | ||
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68788-6936 | 68788-6936-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68788-6936 | 68788-6936-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68788-6936 | 68788-6936-8 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 68788-6936 | 68788-6936-1 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065489-001 | CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 |
| A065489-002 | CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065489-001 | AB |
| A065489-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065489-001 | CLARITHROMYCIN | 250MG | TABLET / ORAL | AB | RS | 2012-07-25 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065489-002 | CLARITHROMYCIN | 500MG | TABLET / ORAL | AB | RS | 2012-07-25 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A065489-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065489-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065489-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065489-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065489-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065489-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065489-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065489-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065489-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065489-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065489-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065489-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065489-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065489-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065489-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065489-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065489-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065489-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065489-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065489-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065489-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065489-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065489-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065489-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065489-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065489-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065489-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065489-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065489-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065489-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065489-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065489-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065489-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065489-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065489-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065489-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065489-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065489-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065489-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065489-002 | AB | 1 | 782e0a99824c… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Clarithromycin | CLARITHROMYCIN | Sportpharm LLC | d836ae7e-fdbf-4dcb-a90d-ede1dcbc3e67 | 2026-06-24 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | REMEDYREPACK INC. | 9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c6 | 2026-06-24 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | Proficient Rx LP | 88c7ded8-333c-408d-b693-a72881710f59 | 2026-04-01 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | Preferred Pharmaceuticals Inc. | 81c0c69e-b1ae-42f3-9e85-09b8daa75d8d | 2026-03-30 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | Major Pharmaceuticals | d0a66646-6774-4fc6-9b26-a98c3a5df274 | 2026-03-26 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | American Health Packaging | fa69ea92-0b41-43fb-918f-ed80e0dedf04 | 2026-03-04 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | AvPAK | 1920f943-bbf1-cfd9-7475-96a35680a9e0 | 2026-02-11 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | Northwind Health Company, LLC | 471f638a-9dd1-09d3-e063-6294a90a2d4f | 2026-01-08 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | Direct_Rx | 3ba1da51-ba5b-323f-e063-6294a90a0333 | 2025-09-08 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | PD-Rx Pharmaceuticals, Inc. | ba216276-b0bd-420a-9e0d-090bdfcc2460 | 2025-08-05 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | A-S Medication Solutions | 25debd85-0840-4f8d-9898-027772061dd2 | 2025-06-09 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | NuCare Pharmaceuticals,Inc. | 9143b79c-4c79-43ac-e053-2995a90ad708 | 2025-02-04 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | Bryant Ranch Prepack | 0c7d8391-50ef-4827-abe6-e0fc0c2f1636 | 2024-01-16 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | Rising Pharma Holdings, Inc. | 0c4db97f-f4c9-4cac-9f12-9db1d967ebeb | 2024-01-05 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | Aurobindo Pharma Limited | 9aaffb41-408c-4372-8fd5-1d649450c0e9 | 2023-10-10 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | A-S Medication Solutions | 1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea23 | 2023-07-31 | Warnings, Adverse reactions | 065489 ANDA065489 |
| Clarithromycin | CLARITHROMYCIN | Proficient Rx LP | b1bdf526-4f16-4130-b614-4cb678f060d7 | 2021-01-01 | Warnings, Adverse reactions | 065489 ANDA065489 |