Fluoxetine
- Product NDC
- 50436-1930
- 11-digit product format
- 504361930
- Labeler code
- 50436
- Product ID
- 50436-1930_6adc2341-dddd-4769-b7fc-dbf9af6d9eef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluoxetine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA078619
- Marketing category
- ANDA
- Marketing start
- 2008-01-31
- Marketing end
- 0000-00-00
- Substance
- FLUOXETINE HYDROCHLORIDE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 50436-1930 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 50436-1930 | 50436-1930-1 | I | Inactivated by FDA | 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 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50436-1930-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 50436-1930-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 50436-1930-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 50436-1930-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 50436-1930-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 50436-1930-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 50436-1930-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 50436-1930-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 50436-1930-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 50436-1930-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 50436-1930-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 50436-1930-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 50436-1930-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 50436-1930-1 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 50436-1930-1 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 50436-1930-1 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 50436-1930-1 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 50436-1930-1 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 50436-1930-1 | 8dfbde2a14a4… | c9ff85d89658… |
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… |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-1930-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4698-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-1930-1 | Fluoxetine | 30 in 1 BOTTLE | CAPSULE | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-1930 | FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [UNIT DOSE SERVICES] | 2 | Legacy NDC, 1 package rows | 20190921_306a045b-9671-4133-b042-3adc617efb93.zip |
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 |
|---|---|---|---|---|
| 310385 | FLUoxetine 20 MG Oral Capsule | PSN | 306a045b-9671-4133-b042-3adc617efb93 | 2 |
| 310385 | fluoxetine 20 MG Oral Capsule | SCD | 306a045b-9671-4133-b042-3adc617efb93 | 2 |
| 310385 | fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral Capsule | SY | 306a045b-9671-4133-b042-3adc617efb93 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-1930-1 | 50436193001 | 30 in 1 BOTTLE | Historical |