Paroxetine
- Product NDC
- 68788-7677
- Requested package NDC
- 68788-7677-6
- 11-digit product format
- 687887677
- Labeler code
- 68788
- Product ID
- 68788-7677_6be7827f-270e-4cf6-803d-0dccd8fbf263
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA203854
- Marketing category
- ANDA
- Marketing start
- 2020-03-02
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- 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 | 68788-7677 | 68788-7677-6 | D | Discontinued by firm | 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… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203854-001 | PAROXETINE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2014-10-31 | |
| A203854-002 | PAROXETINE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2014-10-31 | |
| A203854-003 | PAROXETINE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2014-10-31 | |
| A203854-004 | PAROXETINE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2014-10-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203854-001 | AB |
| A203854-002 | AB |
| A203854-003 | AB |
| A203854-004 | 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 | A203854-001 | PAROXETINE | EQ 10MG BASE | TABLET / ORAL | AB | 2014-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203854-002 | PAROXETINE | EQ 20MG BASE | TABLET / ORAL | AB | 2014-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203854-003 | PAROXETINE | EQ 30MG BASE | TABLET / ORAL | AB | 2014-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203854-004 | PAROXETINE | EQ 40MG BASE | TABLET / ORAL | AB | 2014-10-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203854-001 | PAROXETINE | EQ 10MG BASE | TABLET / ORAL | AB | 2014-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203854-002 | PAROXETINE | EQ 20MG BASE | TABLET / ORAL | AB | 2014-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203854-003 | PAROXETINE | EQ 30MG BASE | TABLET / ORAL | AB | 2014-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203854-004 | PAROXETINE | EQ 40MG BASE | TABLET / ORAL | AB | 2014-10-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203854-001 | PAROXETINE | EQ 10MG BASE | TABLET / ORAL | AB | 2014-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203854-002 | PAROXETINE | EQ 20MG BASE | TABLET / ORAL | AB | 2014-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203854-003 | PAROXETINE | EQ 30MG BASE | TABLET / ORAL | AB | 2014-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203854-004 | PAROXETINE | EQ 40MG BASE | TABLET / ORAL | AB | 2014-10-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203854-001 | PAROXETINE | EQ 10MG BASE | TABLET / ORAL | AB | 2014-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203854-002 | PAROXETINE | EQ 20MG BASE | TABLET / ORAL | AB | 2014-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203854-003 | PAROXETINE | EQ 30MG BASE | TABLET / ORAL | AB | 2014-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203854-004 | PAROXETINE | EQ 40MG BASE | TABLET / ORAL | AB | 2014-10-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203854-001 | PAROXETINE | EQ 10MG BASE | TABLET / ORAL | AB | 2014-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203854-002 | PAROXETINE | EQ 20MG BASE | TABLET / ORAL | AB | 2014-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203854-003 | PAROXETINE | EQ 30MG BASE | TABLET / ORAL | AB | 2014-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203854-004 | PAROXETINE | EQ 40MG BASE | TABLET / ORAL | AB | 2014-10-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203854-001 | PAROXETINE | EQ 10MG BASE | TABLET / ORAL | AB | 2014-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203854-002 | PAROXETINE | EQ 20MG BASE | TABLET / ORAL | AB | 2014-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203854-003 | PAROXETINE | EQ 30MG BASE | TABLET / ORAL | AB | 2014-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203854-004 | PAROXETINE | EQ 40MG BASE | TABLET / ORAL | AB | 2014-10-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203854-001 | PAROXETINE | EQ 10MG BASE | TABLET / ORAL | AB | 2014-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203854-002 | PAROXETINE | EQ 20MG BASE | TABLET / ORAL | AB | 2014-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203854-003 | PAROXETINE | EQ 30MG BASE | TABLET / ORAL | AB | 2014-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203854-004 | PAROXETINE | EQ 40MG BASE | TABLET / ORAL | AB | 2014-10-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203854-001 | PAROXETINE | EQ 10MG BASE | TABLET / ORAL | AB | 2014-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203854-002 | PAROXETINE | EQ 20MG BASE | TABLET / ORAL | AB | 2014-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203854-003 | PAROXETINE | EQ 30MG BASE | TABLET / ORAL | AB | 2014-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203854-004 | PAROXETINE | EQ 40MG BASE | TABLET / ORAL | AB | 2014-10-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203854-001 | PAROXETINE | EQ 10MG BASE | TABLET / ORAL | AB | 2014-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203854-002 | PAROXETINE | EQ 20MG BASE | TABLET / ORAL | AB | 2014-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203854-003 | PAROXETINE | EQ 30MG BASE | TABLET / ORAL | AB | 2014-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203854-004 | PAROXETINE | EQ 40MG BASE | TABLET / ORAL | AB | 2014-10-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203854-001 | PAROXETINE | EQ 10MG BASE | TABLET / ORAL | AB | 2014-10-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203854-002 | PAROXETINE | EQ 20MG BASE | TABLET / ORAL | AB | 2014-10-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203854-003 | PAROXETINE | EQ 30MG BASE | TABLET / ORAL | AB | 2014-10-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203854-004 | PAROXETINE | EQ 40MG BASE | TABLET / ORAL | AB | 2014-10-31 | 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 | A203854-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203854-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203854-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203854-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203854-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203854-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203854-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203854-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203854-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203854-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203854-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203854-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203854-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203854-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203854-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203854-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203854-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203854-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203854-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203854-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203854-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203854-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203854-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203854-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203854-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203854-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203854-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203854-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203854-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203854-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203854-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203854-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203854-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203854-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203854-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203854-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203854-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203854-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203854-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203854-004 | AB | 1 | d06236e962d9… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7677-1 | EA - Each | 68788-7677 | 986c66ec-6b5a-407e-8a83-2ea8b0c8ce13 | 1 | 2020-06-05 |
| 68788-7677-3 | EA - Each | 68788-7677 | 93316b25-2b15-4330-a986-e5b878a32b2c | 1 | 2020-06-05 |
| 68788-7677-6 | EA - Each | 68788-7677 | 5be94218-f792-4b27-914a-33605e5a181c | 1 | 2020-06-05 |
| 68788-7677-8 | EA - Each | 68788-7677 | e844347e-6fe4-4beb-8cbc-f4dabfb4b493 | 1 | 2020-06-05 |
| 68788-7677-9 | EA - Each | 68788-7677 | 6405a815-f114-4077-bd92-f03b3f185d4e | 1 | 2020-06-05 |
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 HYDROCHLORIDE HEMIHYDRATE | REMEDYREPACK INC. | 88b4c469-19b3-44b9-a378-c7c3f4f436db | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | REMEDYREPACK INC. | 4cb9dc05-adb8-4c88-ad40-af8c0df1cafd | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | REMEDYREPACK INC. | 22174520-4b78-4841-96f7-530ba12d2cf1 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | REMEDYREPACK INC. | 90c129a8-afce-4b8b-85d7-f89e6da2aef7 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | REMEDYREPACK INC. | 009d8b89-eab9-43ba-b077-86bfa993a745 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | REMEDYREPACK INC. | 28ddc9e0-05c5-482f-9371-60bbee451b33 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | NuCare Pharmaceuticals, Inc. | 54efbbc1-4f5f-262d-e063-6394a90aadbc | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | NuCare Pharmaceuticals, Inc. | 49dd0858-685f-f46b-e063-6294a90a7f39 | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | NuCare Pharmaceuticals, Inc. | 34909bfb-b4ad-25c4-e063-6294a90a0296 | 2025-08-13 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | PD-Rx Pharmaceuticals, Inc. | d551f3d0-9503-45bd-b701-dfed4c8a5e1e | 2025-02-19 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | PD-Rx Pharmaceuticals, Inc. | 65c81817-34d3-4c57-a4bf-fb10be98386d | 2025-02-19 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Preferred Pharmaceuticals Inc. | 91c5a321-e174-4d86-9a84-e5e278d45aff | 2025-02-13 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Solco Healthcare US, LLC | 6cfde064-ddcb-49df-a53c-953c40eb1470 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Bryant Ranch Prepack | ac6ea24f-a9f3-4413-8c3a-9e2e4ca93c0f | 2024-06-28 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Proficient Rx LP | ce168c41-a860-45f5-bae8-7b3d9b48d86a | 2024-06-27 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Proficient Rx LP | 903e4ef1-487d-4b65-9038-b05ceaf74d19 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | A-S Medication Solutions | 525884d7-e2ee-4d57-a6c9-bd129e9fb9d0 | 2023-11-22 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | NCS HealthCare of KY, LLC dba Vangard Labs | c3b2ce88-6f09-4f7b-ac73-93dca84aa3b8 | 2022-09-02 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Proficient Rx LP | 8526c68d-221c-4822-9532-1d7868cff35e | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 203854 ANDA203854 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68788-7677-6 | 68788767706 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-7677-6) | 2020-03-02 | 0000-00-00 | No | No | Current |