Paroxetine
- Product NDC
- 50090-2143
- Requested package NDC
- 50090-2143-0
- 11-digit product format
- 500902143
- Labeler code
- 50090
- Product ID
- 50090-2143_67dd70df-0747-4d04-ae19-6fda76e9a147
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078406
- Marketing category
- ANDA
- Marketing start
- 2009-12-03
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE ANHYDROUS
- Active strength
- 10 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 package | package | 50090-2143 | 50090-2143-0 | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078406-001 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | |
| A078406-002 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | |
| A078406-003 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | |
| A078406-004 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078406-001 | AB |
| A078406-002 | AB |
| A078406-003 | AB |
| A078406-004 | 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 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-07-25 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078406-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078406-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078406-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078406-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078406-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078406-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078406-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078406-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078406-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078406-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078406-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078406-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078406-004 | AB | 1 | d06236e962d9… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2ace441e-5ed1-9a56-64e5-302d887093bd | Product name | 7 | 20250107 |
| ba9fc237-0e76-4ac8-d3c5-cdb4df9e9f7f | Product name | 4 | 20220524 |
| 200c61bf-0879-1df7-72b7-b72a8497b114 | Product name | 3 | 20171006 |
| b430fc19-562d-420b-53a2-64d42b938631 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 50090-2143-0 | 2023-01-30 | Paroxetine Tablets, USP Rx only |
| 50090-2143-1 | 2023-01-30 | Paroxetine Tablets, USP Rx only |
| 50090-2143-0 | 2021-06-16 | Paroxetine Tablets, USP Rx only |
| 50090-2143-1 | 2021-06-16 | Paroxetine Tablets, USP Rx only |
| 50090-2143-0 | 2020-01-31 | Paroxetine Tablets, USP Rx only |
| 50090-2143-1 | 2020-01-31 | Paroxetine Tablets, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-2143-0 | Paroxetine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 12 | |
| 50090-2143-1 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-2143 | PAROXETINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 12 | Legacy NDC, 2 package rows | 20210616_ec4e1e42-713c-41ea-b62d-2f46b8b5be05.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 |
|---|---|---|---|---|---|---|
| Paroxetine | PAROXETINE | REMEDYREPACK INC. | f52ca1fc-fbf7-4b2b-9e74-975c310b8ce6 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 |
| Paroxetine | PAROXETINE HYDROCHLORIDE | NorthStar Rx LLC | 118320de-0632-4139-8b13-7428b41da0ac | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 |
| Paroxetine | PAROXETINE | AvPAK | d9a5e0aa-e638-5d6e-75c2-20cb78fc4f43 | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 |
| Paroxetine | PAROXETINE | Aurolife Pharma LLC | e1ea4019-bb66-403c-a3d5-6ae056a59116 | 2025-06-07 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 |
| Paroxetine | PAROXETINE HYDROCHLORIDE | Aurobindo Pharma Limited | 326e8ab0-6886-4749-9544-885b37070051 | 2025-05-15 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 |
| Paroxetine | PAROXETINE | NCS HealthCare of KY, LLC dba Vangard Labs | 0a8a58c7-5008-4c65-ae0e-e4ee809b1807 | 2022-09-02 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 |
| Paroxetine | PAROXETINE | Proficient Rx LP | 847118ec-c139-466c-834b-1ae0b6e1f791 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 |
| Paroxetine | PAROXETINE | Aphena Pharma Solutions - Tennessee, LLC | 662223ec-3b9b-4a85-9680-789522363a7b | 2018-07-26 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 |
| Paroxetine | PAROXETINE | Aphena Pharma Solutions - Tennessee, LLC | 30fd2fc4-f661-44c9-a9a9-9d0de0892e3c | 2018-05-08 | Boxed warning, Warnings, Adverse reactions | 078406 ANDA078406 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1738483 | PARoxetine HCl 10 MG Oral Tablet | PSN | ec4e1e42-713c-41ea-b62d-2f46b8b5be05 | 12 |
| 1738495 | PARoxetine HCl 20 MG Oral Tablet | PSN | ec4e1e42-713c-41ea-b62d-2f46b8b5be05 | 12 |
| 1738483 | paroxetine hydrochloride 10 MG Oral Tablet | SCD | ec4e1e42-713c-41ea-b62d-2f46b8b5be05 | 12 |
| 1738495 | paroxetine hydrochloride 20 MG Oral Tablet | SCD | ec4e1e42-713c-41ea-b62d-2f46b8b5be05 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-2143-0 | 50090214300 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-2143-0) | 2015-10-20 | 0000-00-00 | No | No | Current |