Azithromycin
- Product NDC
- 65862-642
- 11-digit product format
- 658620642
- Labeler code
- 65862
- Product ID
- 65862-642_db155bb5-7adc-494a-be66-a2e8e4a45fe1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA207398
- Marketing category
- ANDA
- Marketing start
- 2018-07-05
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 65862-642 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-10 | ||
| unfinished package | package | 65862-642 | 65862-642-12 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-10 | |
| unfinished package | package | 65862-642 | 65862-642-55 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-10 |
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65862-642-55 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65862-642-12 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65862-642-55 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65862-642-12 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65862-642-55 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65862-642-12 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65862-642-55 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65862-642-12 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65862-642-55 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65862-642-12 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65862-642-55 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65862-642-12 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65862-642-55 | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65862-642-12 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 65862-642-55 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 65862-642-12 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 65862-642-55 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 65862-642-12 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 65862-642-55 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 65862-642-12 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | 27f29a85d7e4… | 1372111e901f… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 65862-642-55 | 27f29a85d7e4… | 1372111e901f… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 65862-642-12 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 65862-642-55 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 65862-642-12 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 65862-642-55 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 65862-642-12 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 65862-642-55 | 50b4072663b7… | eae3003ed65e… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 65862-642-12 | 50b4072663b7… | eae3003ed65e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished product | product | 906f6e251498… | bf70b80e44f0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 65862-642-55 | 906f6e251498… | bf70b80e44f0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 65862-642-12 | 906f6e251498… | bf70b80e44f0… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished product | product | 6db9cb8d1e19… | 3449e1ec5b70… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 65862-642-55 | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 65862-642-12 | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished product | product | 8fc7167e32ce… | e96bbc724034… | |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 65862-642-55 | 8fc7167e32ce… | e96bbc724034… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 65862-642-12 | 8fc7167e32ce… | e96bbc724034… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished product | product | 4184dd79f89f… | 545327b3e20f… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 65862-642-12 | 4184dd79f89f… | 545327b3e20f… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 65862-642-55 | 4184dd79f89f… | 545327b3e20f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207398-001 | AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207398-001 | 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 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A207398-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-07-05 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207398-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207398-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207398-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207398-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207398-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207398-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207398-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207398-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207398-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207398-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207398-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207398-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207398-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207398-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207398-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A207398-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A207398-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A207398-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A207398-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A207398-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207398-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A207398-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A207398-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A207398-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A207398-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A207398-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A207398-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207398-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A207398-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A207398-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207398-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207398-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207398-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207398-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A207398-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A207398-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207398-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A207398-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A207398-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A207398-001 | AB | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azithromycin
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AZITHROMYCIN DIHYDRATE | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5FD1131I7S | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 795c13cd-e9ca-481b-9fa9-2890bdf9dac8 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401 | Product name | 9 | 20200616 |
| a2cbe82e-b432-4f71-954b-75e9214e8567 | Product name | 3 | 20200612 |
| 371533fa-efb3-4c48-b5e4-60179db407f3 | Product name | 3 | 20190124 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-642-30 | Azithromycin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 8 | |
| 65862-642-64 | Azithromycin | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 8 | |
| 65862-642-64 | Azithromycin | 3 in 1 BLISTER PACK | TABLET, FILM COATED | 3 | 8 | |
| 65862-642-90 | Azithromycin | 3 in 1 BLISTER PACK | TABLET, FILM COATED | 3 | 8 | |
| 65862-642-90 | Azithromycin | 3 in 1 CARTON | TABLET, FILM COATED | 3 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-642-30 | EA - Each | 65862-642 | 29258a99-8868-4b21-8205-6a160d572675 | 1 | 2018-09-05 |
| 65862-642-64 | EA - Each | 65862-642 | bf4929a2-3c3f-442b-b149-97a87e43d1ce | 1 | 2018-09-05 |
| 65862-642-90 | EA - Each | 65862-642 | e284674a-09d4-4050-b107-f63b7c21f82a | 1 | 2019-02-13 |
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 |
|---|---|---|---|---|---|---|
| Azithromycin | AZITHROMYCIN | A-S Medication Solutions | 882f71b1-b153-4856-b4a7-1a29ae9cf247 | 2026-07-29 | Warnings, Adverse reactions | 207398 ANDA207398 |
| Azithromycin | AZITHROMYCIN | A-S Medication Solutions | 58308e8b-57bd-4e82-a2e8-24aac63194cd | 2026-07-23 | Warnings, Adverse reactions | 207398 ANDA207398 |
| Azithromycin | AZITHROMYCIN | Bryant Ranch Prepack | 2a8010dc-700f-45d3-94ca-ebe4a51acc1b | 2026-07-20 | Warnings, Adverse reactions | 207398 ANDA207398 |
| Azithromycin | AZITHROMYCIN | Aurobindo Pharma Limited | 795c13cd-e9ca-481b-9fa9-2890bdf9dac8 | 2026-04-16 | Warnings, Adverse reactions | 207398 ANDA207398 65862-642 |
| Azithromycin | AZITHROMYCIN | Bryant Ranch Prepack | a81212ef-76b6-4bd7-8706-3d2b05ee34f9 | 2026-03-30 | Warnings, Adverse reactions | 207398 ANDA207398 |
| Azithromycin | AZITHROMYCIN | A-S Medication Solutions | 24c07398-84ad-48e2-9625-e9073c28fb73 | 2026-03-24 | Warnings, Adverse reactions | 207398 ANDA207398 |
| Azithromycin | AZITHROMYCIN | A-S Medication Solutions | 77c5e4c6-6d16-40fe-bf36-cb441348f39b | 2026-03-24 | Warnings, Adverse reactions | 207398 ANDA207398 |
| Azithromycin | AZITHROMYCIN | Preferred Pharmaceuticals Inc. | 003307c5-3f73-4a5d-a704-bfdea3c656e8 | 2026-03-16 | Warnings, Adverse reactions | 207398 ANDA207398 |
| Azithromycin | AZITHROMYCIN | Redpharm Drug | 2fd25741-f014-3999-e063-6394a90acdd0 | 2025-12-27 | Warnings, Adverse reactions | 207398 ANDA207398 |
| Azithromycin | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 94e17ae5-0871-67a0-e053-2995a90ae0ae | 2025-12-19 | Warnings, Adverse reactions | 207398 ANDA207398 |
| AZITHROMYCIN | AZITHROMYCIN | Direct_Rx | 8e6e11fb-eb9e-28ec-e053-2a95a90aa1a3 | 2025-01-22 | Warnings, Adverse reactions | 207398 ANDA207398 |
| Azithromycin | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 9270e676-3382-6483-e053-2a95a90a556e | 2024-06-19 | Warnings, Adverse reactions | 207398 ANDA207398 |
| Azithromycin | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | 8e7184e1-3c3c-cd87-e053-2a95a90a6eb6 | 2024-06-18 | Warnings, Adverse reactions | 207398 ANDA207398 |
| Azithromycin | AZITHROMYCIN | Proficient Rx LP | 25f2d819-ae38-4061-a897-bbcfce3739bf | 2022-03-01 | Warnings, Adverse reactions | 207398 ANDA207398 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 248656 | azithromycin 500 MG Oral Tablet | PSN | 77c5e4c6-6d16-40fe-bf36-cb441348f39b | 11 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | 77c5e4c6-6d16-40fe-bf36-cb441348f39b | 11 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | 77c5e4c6-6d16-40fe-bf36-cb441348f39b | 11 |
| 749780 | {3 (azithromycin 500 MG Oral Tablet) } Pack | GPCK | 795c13cd-e9ca-481b-9fa9-2890bdf9dac8 | 8 |
| 749783 | {6 (azithromycin 250 MG Oral Tablet) } Pack | GPCK | 795c13cd-e9ca-481b-9fa9-2890bdf9dac8 | 8 |
| 308460 | azithromycin 250 MG Oral Tablet | PSN | 795c13cd-e9ca-481b-9fa9-2890bdf9dac8 | 8 |
| 749783 | azithromycin 250 MG Oral Tablet 6 Count Pack | PSN | 795c13cd-e9ca-481b-9fa9-2890bdf9dac8 | 8 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | 795c13cd-e9ca-481b-9fa9-2890bdf9dac8 | 8 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | 24c07398-84ad-48e2-9625-e9073c28fb73 | 8 |
| 749780 | azithromycin 500 MG Oral Tablet 3 Count Pack | PSN | 795c13cd-e9ca-481b-9fa9-2890bdf9dac8 | 8 |
| 308460 | azithromycin 250 MG Oral Tablet | SCD | 795c13cd-e9ca-481b-9fa9-2890bdf9dac8 | 8 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | 795c13cd-e9ca-481b-9fa9-2890bdf9dac8 | 8 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | 24c07398-84ad-48e2-9625-e9073c28fb73 | 8 |
| 749783 | azithromycin 250 MG Oral Tablet 6 Count Pack | SY | 795c13cd-e9ca-481b-9fa9-2890bdf9dac8 | 8 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | 24c07398-84ad-48e2-9625-e9073c28fb73 | 8 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | 795c13cd-e9ca-481b-9fa9-2890bdf9dac8 | 8 |
| 749780 | azithromycin 500 MG Oral Tablet 3 Count Pack | SY | 795c13cd-e9ca-481b-9fa9-2890bdf9dac8 | 8 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | 003307c5-3f73-4a5d-a704-bfdea3c656e8 | 7 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | 003307c5-3f73-4a5d-a704-bfdea3c656e8 | 7 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | 003307c5-3f73-4a5d-a704-bfdea3c656e8 | 7 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | a81212ef-76b6-4bd7-8706-3d2b05ee34f9 | 6 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | a81212ef-76b6-4bd7-8706-3d2b05ee34f9 | 6 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | a81212ef-76b6-4bd7-8706-3d2b05ee34f9 | 6 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | 94e17ae5-0871-67a0-e053-2995a90ae0ae | 5 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | 94e17ae5-0871-67a0-e053-2995a90ae0ae | 5 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | 94e17ae5-0871-67a0-e053-2995a90ae0ae | 5 |
| 749780 | {3 (azithromycin 500 MG Oral Tablet) } Pack | GPCK | 2fd25741-f014-3999-e063-6394a90acdd0 | 3 |
| 749780 | {3 (azithromycin 500 MG Oral Tablet) } Pack | GPCK | 1ef293bd-b99c-42ba-9c9b-6e0cd5e350b5 | 3 |
| 749780 | {3 (azithromycin 500 MG Oral Tablet) } Pack | GPCK | 8e7184e1-3c3c-cd87-e053-2a95a90a6eb6 | 3 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | 2fd25741-f014-3999-e063-6394a90acdd0 | 3 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | 8e6e11fb-eb9e-28ec-e053-2a95a90aa1a3 | 3 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | 8e7184e1-3c3c-cd87-e053-2a95a90a6eb6 | 3 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | 1ef293bd-b99c-42ba-9c9b-6e0cd5e350b5 | 3 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | 9270e676-3382-6483-e053-2a95a90a556e | 3 |
| 749780 | azithromycin 500 MG Oral Tablet 3 Count Pack | PSN | 1ef293bd-b99c-42ba-9c9b-6e0cd5e350b5 | 3 |
| 749780 | azithromycin 500 MG Oral Tablet 3 Count Pack | PSN | 8e7184e1-3c3c-cd87-e053-2a95a90a6eb6 | 3 |
| 749780 | azithromycin 500 MG Oral Tablet 3 Count Pack | PSN | 2fd25741-f014-3999-e063-6394a90acdd0 | 3 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | 9270e676-3382-6483-e053-2a95a90a556e | 3 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | 8e7184e1-3c3c-cd87-e053-2a95a90a6eb6 | 3 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | 2fd25741-f014-3999-e063-6394a90acdd0 | 3 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | 8e6e11fb-eb9e-28ec-e053-2a95a90aa1a3 | 3 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | 1ef293bd-b99c-42ba-9c9b-6e0cd5e350b5 | 3 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | 8e6e11fb-eb9e-28ec-e053-2a95a90aa1a3 | 3 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | 1ef293bd-b99c-42ba-9c9b-6e0cd5e350b5 | 3 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | 8e7184e1-3c3c-cd87-e053-2a95a90a6eb6 | 3 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | 9270e676-3382-6483-e053-2a95a90a556e | 3 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | 2fd25741-f014-3999-e063-6394a90acdd0 | 3 |
| 749780 | azithromycin 500 MG Oral Tablet 3 Count Pack | SY | 1ef293bd-b99c-42ba-9c9b-6e0cd5e350b5 | 3 |
| 749780 | azithromycin 500 MG Oral Tablet 3 Count Pack | SY | 8e7184e1-3c3c-cd87-e053-2a95a90a6eb6 | 3 |
| 749780 | azithromycin 500 MG Oral Tablet 3 Count Pack | SY | 2fd25741-f014-3999-e063-6394a90acdd0 | 3 |
| 749780 | {3 (azithromycin 500 MG Oral Tablet) } Pack | GPCK | 25f2d819-ae38-4061-a897-bbcfce3739bf | 2 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | 25f2d819-ae38-4061-a897-bbcfce3739bf | 2 |
| 749780 | azithromycin 500 MG Oral Tablet 3 Count Pack | PSN | 25f2d819-ae38-4061-a897-bbcfce3739bf | 2 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | 25f2d819-ae38-4061-a897-bbcfce3739bf | 2 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | 25f2d819-ae38-4061-a897-bbcfce3739bf | 2 |
| 749780 | azithromycin 500 MG Oral Tablet 3 Count Pack | SY | 25f2d819-ae38-4061-a897-bbcfce3739bf | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65862-642-12 | 65862064212 | 12500 TABLET, FILM COATED in 1 BAG (65862-642-12) | 16-SEP-20 | Current | ||||
| 65862-642-30 | 65862064230 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-642-30) | 2018-07-05 | 0000-00-00 | No | No | Current | |
| 65862-642-55 | 65862064255 | 15000 TABLET, FILM COATED in 1 BAG (65862-642-55) | 16-SEP-20 | Current | ||||
| 65862-642-64 | 65862064264 | 1 BLISTER PACK in 1 CARTON (65862-642-64) / 3 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2018-07-05 | 0000-00-00 | No | No | Current |
| 65862-642-90 | 65862064290 | 3 BLISTER PACK in 1 CARTON (65862-642-90) / 3 TABLET, FILM COATED in 1 BLISTER PACK | 3 blister pack | 2018-07-05 | 0000-00-00 | No | No | Current |