Fluoxetine
- Product NDC
- 65862-194
- 11-digit product format
- 658620194
- Labeler code
- 65862
- Product ID
- 65862-194_7dd85e52-3c8c-4ca2-b9fa-0dfaed81123e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2008-01-31
- Marketing end
- 2028-02-29
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- 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 | 65862-194 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-03 | ||
| unfinished package | package | 65862-194 | 65862-194-22 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-03 |
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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 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 | 65862-194-22 | 4184dd79f89f… | 545327b3e20f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished product | product | 4bd3596a7b87… | 5c64c6f6865f… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished package | package | 65862-194-22 | 4bd3596a7b87… | 5c64c6f6865f… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished product | product | 263afe128892… | 91768de4ddbe… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 65862-194-22 | 263afe128892… | 91768de4ddbe… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished product | product | 5b2001dcd8f5… | 54b53d4dc9e4… | |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished package | package | 65862-194-22 | 5b2001dcd8f5… | 54b53d4dc9e4… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078619-001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | |
| A078619-002 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | |
| A078619-003 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | RS | 2008-01-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078619-001 | AB1 |
| A078619-002 | AB1 |
| A078619-003 | 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 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078619-002 | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078619-003 | FLUOXETINE HYDROCHLORIDE | EQ 40MG BASE | CAPSULE / ORAL | AB | 2008-01-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078619-001 | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB1 | 2008-01-31 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078619-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078619-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078619-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078619-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078619-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078619-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078619-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078619-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078619-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078619-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078619-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078619-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078619-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078619-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078619-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078619-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078619-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078619-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078619-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078619-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078619-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078619-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078619-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078619-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078619-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078619-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078619-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078619-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078619-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078619-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078619-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078619-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078619-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078619-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078619-002 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078619-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078619-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078619-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078619-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078619-001 | AB1 | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluoxetine
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FLUOXETINE HYDROCHLORIDE | 40 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| I9W7N6B1KJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 45454555-7402-41cb-a452-e6a76e04f387 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ce7d40ce-bfb8-ee15-a060-423ec90d7ac9 | Product name | 6 | 20250331 |
| e5b459e3-ddce-4802-aab4-2c901d71ae85 | Product name | 5 | 20250129 |
| 6d3d5b3a-d6b8-8417-8428-6414b08f1464 | Product name | 3 | 20240130 |
| e7177a8f-11de-ee90-ca22-068e6ef54cf5 | Product name | 4 | 20230104 |
| 82da1192-6e97-fa73-2f85-6a50c10b4704 | Product name | 3 | 20161212 |
| 877783eb-030c-6e3f-0979-804cf94d8856 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-194-01 | Fluoxetine | 100 in 1 BOTTLE | CAPSULE | 100 | 32 | |
| 65862-194-05 | Fluoxetine | 500 in 1 BOTTLE | CAPSULE | 500 | 32 | |
| 65862-194-30 | Fluoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | 32 | |
| 65862-194-99 | Fluoxetine | 1000 in 1 BOTTLE | CAPSULE | 1000 | 32 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-194-01 | EA - Each | 65862-194 | 5f2cf7a7-1618-478d-ae7d-2bbeecb61477 | 1 | 2012-07-24 |
| 65862-194-05 | EA - Each | 65862-194 | 17115ca2-129f-4ac6-8c8a-fd6f6a267f3f | 1 | 2013-10-17 |
| 65862-194-30 | EA - Each | 65862-194 | 8825073f-ea5c-4c9a-8383-22ad4dc09dd3 | 1 | 2012-07-24 |
| 65862-194-99 | EA - Each | 65862-194 | 6e468648-bac6-4104-93eb-a939594b5fec | 1 | 2013-10-17 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | American Health Packaging | 7bee936b-0130-4a6b-a974-956aef5486d9 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | American Health Packaging | 9965a672-7842-4926-9063-b76317c74862 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | 32afb28a-dc4c-4a7e-9701-1825f805e7df | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | REMEDYREPACK INC. | 20516384-6517-48be-bd6e-718250878a76 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | Unit Dose Solutions, Inc. | 54d9f02c-95ea-99b1-e063-6294a90a9140 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | QPharma Inc | 50253c6e-de36-05e6-e063-6294a90ad7a8 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | a5fa64a6-3de3-4e2e-8b92-6d507fb8eee9 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 992060ee-fb4e-4c6d-9ffe-30902bc63af2 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | PD-Rx Pharmaceuticals, Inc. | 5dc20c8f-0d8f-400c-b850-fe1b7e3e75e3 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | b7b102f0-17a2-49f7-b898-cb2e0fc71b4d | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7d7a196b-91de-4753-8bb6-c6d5c668952d | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | REMEDYREPACK INC. | b8666383-462d-4a21-8f49-1d572da386d1 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | REMEDYREPACK INC. | d1c768b5-64bb-4036-aa92-797b3a5f92eb | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | Northwind Health Company, LLC | 50369762-c7c3-d58e-e063-6294a90af8df | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | A-S Medication Solutions | 679e439a-d955-4b54-8236-a2ccd9a2a10a | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | A-S Medication Solutions | 3ce2f189-4386-4d0d-84f6-6d913ad1c09b | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | NCS HealthCare of KY, LLC dba Vangard Labs | faf4bc0c-bf65-4a65-8f08-3d800185d6a8 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE | BluePoint Laboratories | daf33244-1348-4c34-b44c-9e35d5c48a3e | 2026-03-25 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | 3ccada47-7eb9-285d-5059-06afb4466114 | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
| Fluoxetine | FLUOXETINE HYDROCHLORIDE | Bryant Ranch Prepack | bb06af33-8ff7-0b02-0029-d628f62e1382 | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 078619 ANDA078619 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | a5fa64a6-3de3-4e2e-8b92-6d507fb8eee9 | 35 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | a5fa64a6-3de3-4e2e-8b92-6d507fb8eee9 | 35 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | a5fa64a6-3de3-4e2e-8b92-6d507fb8eee9 | 35 |
| 310384 | FLUoxetine 10 MG Oral Capsule | PSN | 45454555-7402-41cb-a452-e6a76e04f387 | 32 |
| 310385 | FLUoxetine 20 MG Oral Capsule | PSN | 45454555-7402-41cb-a452-e6a76e04f387 | 32 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | 9f069b9b-16e4-4f0e-b420-4aa02ffbb632 | 32 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | 45454555-7402-41cb-a452-e6a76e04f387 | 32 |
| 310384 | fluoxetine 10 MG Oral Capsule | SCD | 45454555-7402-41cb-a452-e6a76e04f387 | 32 |
| 310385 | fluoxetine 20 MG Oral Capsule | SCD | 45454555-7402-41cb-a452-e6a76e04f387 | 32 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | 9f069b9b-16e4-4f0e-b420-4aa02ffbb632 | 32 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | 45454555-7402-41cb-a452-e6a76e04f387 | 32 |
| 310384 | fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule | SY | 45454555-7402-41cb-a452-e6a76e04f387 | 32 |
| 310385 | fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule | SY | 45454555-7402-41cb-a452-e6a76e04f387 | 32 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | 9f069b9b-16e4-4f0e-b420-4aa02ffbb632 | 32 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | 45454555-7402-41cb-a452-e6a76e04f387 | 32 |
| 310385 | FLUoxetine 20 MG Oral Capsule | PSN | 42c4c341-8282-4961-8581-8a0430162559 | 25 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | 42c4c341-8282-4961-8581-8a0430162559 | 25 |
| 310385 | fluoxetine 20 MG Oral Capsule | SCD | 42c4c341-8282-4961-8581-8a0430162559 | 25 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | 42c4c341-8282-4961-8581-8a0430162559 | 25 |
| 310385 | fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule | SY | 42c4c341-8282-4961-8581-8a0430162559 | 25 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | 42c4c341-8282-4961-8581-8a0430162559 | 25 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | 2f302db0-1c88-44cf-8258-3c1c60afb5a4 | 18 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | 2f302db0-1c88-44cf-8258-3c1c60afb5a4 | 18 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | 2f302db0-1c88-44cf-8258-3c1c60afb5a4 | 18 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | 74e1dbee-8d65-442e-834f-8b32c6f1b3f6 | 8 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | 74e1dbee-8d65-442e-834f-8b32c6f1b3f6 | 8 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | 74e1dbee-8d65-442e-834f-8b32c6f1b3f6 | 8 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | 992060ee-fb4e-4c6d-9ffe-30902bc63af2 | 5 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | 992060ee-fb4e-4c6d-9ffe-30902bc63af2 | 5 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | 992060ee-fb4e-4c6d-9ffe-30902bc63af2 | 5 |
| 310384 | FLUoxetine 10 MG Oral Capsule | PSN | 62c47df4-2c71-437e-b142-bc193f6277f0 | 4 |
| 310385 | FLUoxetine 20 MG Oral Capsule | PSN | 62c47df4-2c71-437e-b142-bc193f6277f0 | 4 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | 62c47df4-2c71-437e-b142-bc193f6277f0 | 4 |
| 310384 | fluoxetine 10 MG Oral Capsule | SCD | 62c47df4-2c71-437e-b142-bc193f6277f0 | 4 |
| 310385 | fluoxetine 20 MG Oral Capsule | SCD | 62c47df4-2c71-437e-b142-bc193f6277f0 | 4 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | 62c47df4-2c71-437e-b142-bc193f6277f0 | 4 |
| 310384 | fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule | SY | 62c47df4-2c71-437e-b142-bc193f6277f0 | 4 |
| 310385 | fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule | SY | 62c47df4-2c71-437e-b142-bc193f6277f0 | 4 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | 62c47df4-2c71-437e-b142-bc193f6277f0 | 4 |
| 310384 | FLUoxetine 10 MG Oral Capsule | PSN | 24b0e72d-2dd3-4355-8ba4-6101b127a36b | 3 |
| 310385 | FLUoxetine 20 MG Oral Capsule | PSN | 24b0e72d-2dd3-4355-8ba4-6101b127a36b | 3 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | 9b8d8da5-8c06-0942-e053-2995a90aa2c9 | 3 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | 24b0e72d-2dd3-4355-8ba4-6101b127a36b | 3 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | dfae4357-b6f9-9a30-e053-2995a90a2667 | 3 |
| 310384 | fluoxetine 10 MG Oral Capsule | SCD | 24b0e72d-2dd3-4355-8ba4-6101b127a36b | 3 |
| 310385 | fluoxetine 20 MG Oral Capsule | SCD | 24b0e72d-2dd3-4355-8ba4-6101b127a36b | 3 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | 9b8d8da5-8c06-0942-e053-2995a90aa2c9 | 3 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | 24b0e72d-2dd3-4355-8ba4-6101b127a36b | 3 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | dfae4357-b6f9-9a30-e053-2995a90a2667 | 3 |
| 310384 | fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral Capsule | SY | 24b0e72d-2dd3-4355-8ba4-6101b127a36b | 3 |
| 310385 | fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule | SY | 24b0e72d-2dd3-4355-8ba4-6101b127a36b | 3 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | dfae4357-b6f9-9a30-e053-2995a90a2667 | 3 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | 9b8d8da5-8c06-0942-e053-2995a90aa2c9 | 3 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | 24b0e72d-2dd3-4355-8ba4-6101b127a36b | 3 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | ef699ed0-fd9e-4580-93bb-6fd50499dbd1 | 2 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | ef699ed0-fd9e-4580-93bb-6fd50499dbd1 | 2 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | ef699ed0-fd9e-4580-93bb-6fd50499dbd1 | 2 |
| 313989 | FLUoxetine 40 MG Oral Capsule | PSN | 3e111be4-28f0-c290-e063-6294a90a447f | 1 |
| 313989 | fluoxetine 40 MG Oral Capsule | SCD | 3e111be4-28f0-c290-e063-6294a90a447f | 1 |
| 313989 | fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral Capsule | SY | 3e111be4-28f0-c290-e063-6294a90a447f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65862-194-01 | 65862019401 | 100 CAPSULE in 1 BOTTLE (65862-194-01) | 100 capsule | 2008-01-31 | 2028-02-29 | No | No | Current |
| 65862-194-05 | 65862019405 | 500 CAPSULE in 1 BOTTLE (65862-194-05) | 500 capsule | 2008-01-31 | 2027-04-30 | No | No | Current |
| 65862-194-22 | 65862019422 | 2000 CAPSULE in 1 BAG (65862-194-22) | 2000 capsule | 31-JAN-08 | Current | |||
| 65862-194-30 | 65862019430 | 30 CAPSULE in 1 BOTTLE (65862-194-30) | 30 capsule | 2008-01-31 | 2028-02-29 | No | No | Current |
| 65862-194-99 | 65862019499 | 1000 CAPSULE in 1 BOTTLE (65862-194-99) | 1000 capsule | 2008-01-31 | 2027-02-28 | No | No | Current |