Paroxetine
- Product NDC
- 63629-8114
- 11-digit product format
- 636298114
- Labeler code
- 63629
- Product ID
- 63629-8114_987b9e46-981a-4c3e-9ff2-abeb9e3b4d35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077584
- Marketing category
- ANDA
- Marketing start
- 2007-04-13
- Marketing end
- 0000-00-00
- Substance
- PAROXETINE HYDROCHLORIDE ANHYDROUS
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077584-001 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | |
| A077584-002 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | |
| A077584-003 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | |
| A077584-004 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077584-001 | AB |
| A077584-002 | AB |
| A077584-003 | AB |
| A077584-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A077584-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A077584-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A077584-003 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A077584-004 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A077584-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077584-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077584-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077584-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A077584-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077584-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077584-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077584-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077584-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077584-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077584-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077584-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077584-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077584-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077584-004 | AB | 1 | 2680178bc6a6… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 | Zydus Pharmaceuticals USA Inc. | a6bb4f0a-1555-4550-a7a4-99609674b1e7 | 2025-01-07 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Advanced Rx Pharmacy of Tennessee, LLC | fc11a056-7db5-1966-e053-6394a90aa59c | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE HYDROCHLORIDE | Zydus Lifesciences Limited | 6d5fcdb2-4d84-4b20-87e3-58a43e567500 | 2024-12-03 | 077584 ANDA077584 | |
| Paroxetine | PAROXETINE | Bryant Ranch Prepack | 40dcf270-64bb-bca0-db08-6b233a3430f8 | 2024-08-29 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | NuCare Pharmaceuticals,Inc. | 570a9f0d-04fb-2922-e054-00144ff88e88 | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Proficient Rx LP | 6318eefa-ee51-4e4e-91a5-8760d48bdc63 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-8114-1 | 63629811401 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-8114-1) | 2019-07-25 | 0000-00-00 | No | No | Current |
| 63629-8114-2 | 63629811402 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-8114-2) | 2019-07-25 | 0000-00-00 | No | No | Current |