Paroxetine
- Product NDC
- 68382-098
- 11-digit product format
- 683820098
- Labeler code
- 68382
- Product ID
- 68382-098_c88d98d1-e370-4ad8-869a-603875f276cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paroxetine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA077584
- Marketing category
- ANDA
- Marketing start
- 2007-04-13
- Substance
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- 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
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-001 | PAROXETINE HYDROCHLORIDE | EQ 10MG BASE | TABLET / ORAL | AB | 2007-03-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-002 | PAROXETINE HYDROCHLORIDE | EQ 20MG BASE | TABLET / ORAL | AB | 2007-03-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-003 | PAROXETINE HYDROCHLORIDE | EQ 30MG BASE | TABLET / ORAL | AB | 2007-03-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-004 | PAROXETINE HYDROCHLORIDE | EQ 40MG BASE | TABLET / ORAL | AB | 2007-03-07 | 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 | 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… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077584-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077584-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077584-004 | AB | 1 | d06236e962d9… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Paroxetine
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| X2ELS050D8 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a6bb4f0a-1555-4550-a7a4-99609674b1e7 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2ace441e-5ed1-9a56-64e5-302d887093bd | Product name | 7 | 20250107 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 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 |
|---|---|---|---|---|---|---|
| 68382-098-01 | Paroxetine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 16 | |
| 68382-098-05 | Paroxetine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 16 | |
| 68382-098-06 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 16 | |
| 68382-098-10 | Paroxetine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 16 | |
| 68382-098-16 | Paroxetine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68382-098-01 | EA - Each | 68382-098 | 4967769e-e6d7-4475-8efd-bf308c997a28 | 1 | 2012-07-24 |
| 68382-098-05 | EA - Each | 68382-098 | 1e51249e-8ef4-4e19-ad88-d92d753789f1 | 1 | 2012-07-24 |
| 68382-098-06 | EA - Each | 68382-098 | bc2fba0e-fca6-4bf8-8281-0561f3de57d2 | 1 | 2012-07-24 |
| 68382-098-10 | EA - Each | 68382-098 | 75055fd7-43e8-4f13-8b28-b0b8883a6337 | 1 | 2012-07-24 |
| 68382-098-16 | EA - Each | 68382-098 | 49550ead-27be-4912-b4a1-62dd6780b62c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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. | 679e4b9b-0f7b-450a-aca7-1b448cccbeed | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | HAWAII REPACK, INC. | d5206418-aa7f-42dd-b977-4b9d1e4b2752 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | American Health Packaging | b5a8f864-a53d-48d9-aca6-6b64017fb168 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | REMEDYREPACK INC. | 05ec70fd-4c65-495f-ba12-e8433a10b655 | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | REMEDYREPACK INC. | c002508e-f96c-413b-b232-5d55fceeffe0 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | REMEDYREPACK INC. | bc0efd3b-c6b9-4ed0-b517-6e57e4700b7b | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| PAROXETINE | PAROXETINE | DIRECT RX | 2cfe30fc-9c46-4efd-e054-00144ff8d46c | 2026-03-05 | Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | A-S Medication Solutions | 31e4bb7c-59ab-4cbf-ba08-317c1417b28f | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | A-S Medication Solutions | a809a6b5-18a3-4771-aaf8-7197d1743540 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | NuCare Pharamceuticals, Inc. | 49dc055c-faef-0be3-e063-6394a90a934f | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | PD-Rx Pharmaceuticals, Inc. | c0acc97d-3d8d-4a7f-8acd-99050b0af2f1 | 2025-10-20 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Preferred Pharmaceuticals Inc. | 7d558598-6905-46da-8f34-668456c68411 | 2025-09-08 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc | 605c1d23-c97c-4ea4-92d0-fed351de9d2e | 2025-09-05 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Preferred Pharmaceuticals Inc. | ee38b589-e646-4203-bea5-cc3744fe17c3 | 2025-09-05 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Bryant Ranch Prepack | 0a0f8897-2099-4038-9b96-ed9c4f084018 | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Bryant Ranch Prepack | 7a702760-9b72-4595-bf47-01aff786c74d | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Bryant Ranch Prepack | 07f245c5-fcb0-3008-d69e-10290cadbfa6 | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Asclemed USA, Inc. | 4acd3e7a-4f19-4428-9452-48ce370cb3db | 2025-02-13 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Direct_Rx | fea936a5-fdeb-e4fb-e053-6294a90a8995 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 |
| Paroxetine | PAROXETINE | Zydus Pharmaceuticals USA Inc. | a6bb4f0a-1555-4550-a7a4-99609674b1e7 | 2025-01-07 | Boxed warning, Warnings, Adverse reactions | 077584 ANDA077584 68382-098 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68382-098-01 | 68382009801 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-098-01) | 2007-04-13 | 0000-00-00 | No | No | Current |
| 68382-098-05 | 68382009805 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-098-05) | 2007-04-13 | 0000-00-00 | No | No | Current |
| 68382-098-06 | 68382009806 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-098-06) | 2007-04-13 | 0000-00-00 | No | No | Current |
| 68382-098-10 | 68382009810 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-098-10) | 2007-04-13 | 0000-00-00 | No | No | Current |
| 68382-098-16 | 68382009816 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-098-16) | 2007-04-13 | 0000-00-00 | No | No | Current |