PAROXETINE
- Product NDC
- 60505-0083
- Requested package NDC
- 60505-0083-5
- 11-digit product format
- 605050083
- Labeler code
- 60505
- Product ID
- 60505-0083_9cde2ef4-fd50-ed21-0628-cb6cd8a6153f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA075356
- Marketing category
- ANDA
- Marketing start
- 2003-09-08
- 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
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 60505-0083 | 60505-0083-5 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075356-001 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2003-07-30 | |
| A075356-002 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2003-07-30 | |
| A075356-003 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2003-07-30 | |
| A075356-004 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2003-07-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075356-001 | AB |
| A075356-002 | AB |
| A075356-003 | AB |
| A075356-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A075356-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2003-07-30 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075356-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2003-07-30 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075356-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2003-07-30 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075356-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2003-07-30 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A075356-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075356-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075356-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075356-004 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PAROXETINE | PAROXETINE HYDROCHLORIDE | REMEDYREPACK INC. | 8e176ff2-ed3a-4909-94e1-6b9a3581a621 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 075356 ANDA075356 |
| PAROXETINE | PAROXETINE HYDROCHLORIDE | REMEDYREPACK INC. | beb87e2e-0a8f-43b6-b148-57f0b7191548 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 075356 ANDA075356 |
| PAROXETINE | PAROXETINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | e63fe922-b35a-406c-8737-f3f5e6d5a30d | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 075356 ANDA075356 |
| PAROXETINE | PAROXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 4d3b4536-7900-223c-e063-6294a90a3d60 | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | 075356 ANDA075356 |
| PAROXETINE | PAROXETINE HYDROCHLORIDE | REMEDYREPACK INC. | 98d4f767-06e3-4d9b-b1ad-4b31f7e36130 | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | 075356 ANDA075356 |
| PAROXETINE | PAROXETINE HYDROCHLORIDE | Cardinal Health 107, LLC | 333dfd07-61f0-4b86-b4b5-b04adf64e49f | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | 075356 ANDA075356 |
| PAROXETINE | PAROXETINE HYDROCHLORIDE | Major Pharmaceuticals | 84b1b1f0-d375-4fda-99af-9487f8ef50c7 | 2025-08-07 | Boxed warning, Warnings, Adverse reactions | 075356 ANDA075356 |
| PAROXETINE | PAROXETINE HYDROCHLORIDE | Apotex Corp. | 08320ea3-8f93-6f04-5d1c-f69af3eb5a81 | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | 075356 ANDA075356 60505-0083-5 60505-0083 60505008305 |
| PAROXETINE | PAROXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 1801246b-02c3-430f-932a-b18cb0d13d1d | 2018-11-05 | Boxed warning, Warnings, Adverse reactions | 075356 ANDA075356 |
| PAROXETINE | PAROXETINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | a7128be7-7023-40c4-aa64-29d52145ae31 | 2018-10-17 | Boxed warning, Warnings, Adverse reactions | 075356 ANDA075356 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PAROXETINE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PAROXETINE HYDROCHLORIDE ANHYDROUS | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3I3T11UD2S | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 08320ea3-8f93-6f04-5d1c-f69af3eb5a81 | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60505-0083-0 | PAROXETINE | 12500 in 1 BOTTLE | TABLET, FILM COATED | 12500 | 25 | |
| 60505-0083-1 | PAROXETINE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 25 | |
| 60505-0083-2 | PAROXETINE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 25 | |
| 60505-0083-4 | PAROXETINE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 25 | |
| 60505-0083-5 | PAROXETINE | 10 in 1 CARTON | TABLET, FILM COATED | 10 | 25 | |
| 60505-0083-5 | PAROXETINE | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 25 | |
| 60505-0083-9 | PAROXETINE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 25 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-0083-0 | EA - Each | 60505-0083 | 5e74666a-9382-40da-bc14-375c2da86c9b | 1 | 2012-07-24 |
| 60505-0083-1 | EA - Each | 60505-0083 | 91c0554f-c195-4b7a-b8ce-631d037605ae | 1 | 2012-07-24 |
| 60505-0083-2 | EA - Each | 60505-0083 | e8f0d31c-eba5-4832-b3e5-8445f638d89a | 1 | 2012-07-24 |
| 60505-0083-4 | EA - Each | 60505-0083 | 4bf6231f-3470-4d38-b5d5-ff245adc8041 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 60505-0083 | PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [APOTEX CORP.] | 24 | Current NDC, Legacy NDC, 7 package rows | 20250411_08320ea3-8f93-6f04-5d1c-f69af3eb5a81.zip |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 60505-0083-5 | 60505008305 | 10 BLISTER PACK in 1 CARTON (60505-0083-5) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2003-09-08 | 0000-00-00 | No | No | Current |