NDC 68788-8829-08 - Paroxetine
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68788-8829
- Requested NDC
- 68788-8829-08
- Package NDCs from labels
- 68788-8829-3, 68788-8829-6, 68788-8829-9, 68788-8829-1, 68788-8829-8, 68788-8829-08
- Manufacturer
- Preferred Pharmaceuticals Inc.
- Effective date
- 2025-02-13
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Paroxetine - Preferred Pharmaceuticals Inc. | Preferred Pharmaceuticals Inc. | 2025-02-13 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-8829-1 | Paroxetine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 1 | |
| 68788-8829-3 | Paroxetine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 1 | |
| 68788-8829-6 | Paroxetine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 1 | |
| 68788-8829-8 | Paroxetine | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | 1 | |
| 68788-8829-9 | Paroxetine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-8829 | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 5 package rows | 20250216_91c5a321-e174-4d86-9a84-e5e278d45aff.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-8829-1 | EA - Each | 68788-8829 | 0993ef2c-a809-4b32-9f73-e12d0542bdaf | 1 | 2025-03-04 |
| 68788-8829-3 | EA - Each | 68788-8829 | 4a6225cd-d838-42e8-adba-4a41b50ae12f | 1 | 2025-03-04 |
| 68788-8829-6 | EA - Each | 68788-8829 | ddd247ff-82a2-4109-97eb-a2376ba72bd3 | 1 | 2025-03-04 |
| 68788-8829-8 | EA - Each | 68788-8829 | 3cb51ac7-86c3-4266-bab0-a7d970703609 | 1 | 2025-05-14 |
| 68788-8829-9 | EA - Each | 68788-8829 | 0564912d-5c8f-46fc-bf67-8684d9dc0e92 | 1 | 2025-03-04 |
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 | ANDA203854 X2ELS050D8 |
| Paroxetine | PAROXETINE | REMEDYREPACK INC. | f52ca1fc-fbf7-4b2b-9e74-975c310b8ce6 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | 1738483 X2ELS050D8 |
| Paroxetine | PAROXETINE | REMEDYREPACK INC. | 679e4b9b-0f7b-450a-aca7-1b448cccbeed | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 1738503 X2ELS050D8 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | REMEDYREPACK INC. | 4cb9dc05-adb8-4c88-ad40-af8c0df1cafd | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | ANDA203854 1738495 X2ELS050D8 |
| True Coast SPF 50 Mineral Sunscreen | ZINC OXIDE 18%, TITANIUM DIOXIDE 6% | Foshan Sugar Max Cosmetics CO.,Ltd | 5379466d-8d14-5fc2-e063-6394a90abd7e | 2026-07-22 | Warnings | 15FIX9V2JP |
| Calamine | CALAMINE AND ZINC OXIDE | Marie's Original Formulas LLC | 57110309-9a3d-025f-e063-6394a90a015a | 2026-07-22 | Warnings | 1K09F3G675 |
| Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation | OCTINOXATE AND TITANIUM DIOXIDE | SICOS ET CIE | 571f23e9-1126-e32d-e063-6294a90a9951 | 2026-07-21 | Warnings | 15FIX9V2JP |
| MENS SPF50 ALL IN ONE SUNSCREEN | MENS SPF50 ALL IN ONE SUNSCREEN | Lance (Guangzhou) Biological Technology Co., Ltd. | 57074480-77fd-cc06-e063-6294a90a28d4 | 2026-07-20 | Warnings | 15FIX9V2JP |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | REMEDYREPACK INC. | 22174520-4b78-4841-96f7-530ba12d2cf1 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | ANDA203854 1738511 X2ELS050D8 |
| Calamine | CALAMINE AND ZINC OXIDE | Marie's Original Formulas LLC | 571083ce-cd35-a638-e063-6394a90ae4c7 | 2026-07-20 | Warnings | 1K09F3G675 |
| Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation | OCTINOXATE AND TITANIUM DIOXIDE | L'Oreal USA Products Inc | 5711364c-f9b4-bfa6-e063-6294a90ace4a | 2026-07-20 | Warnings | 15FIX9V2JP |
| Calamine | FERRIC OXIDE RED | Better Living Brands, LLC | c7ef0ef3-6861-4b94-af4b-371fee8c1f3d | 2026-07-16 | Warnings, Adverse reactions | 1K09F3G675 |
| Paroxetine | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | REMEDYREPACK INC. | 90c129a8-afce-4b8b-85d7-f89e6da2aef7 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | ANDA203854 1738483 X2ELS050D8 |
| Paroxetine | PAROXETINE HYDROCHLORIDE | NorthStar Rx LLC | 118320de-0632-4139-8b13-7428b41da0ac | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 1738503 1738511 1738495 1738483 X2ELS050D8 |
| Bombee Honey Daily Glow Shield Sunscreen | HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE | ABT ASIA Inc. | 56112dff-b091-7a56-e063-6294a90a77d3 | 2026-07-08 | Warnings | 15FIX9V2JP |
| SKIN-INFUSED FOUNDATION SPF 25- shade BB3 01 | ZINC OXIDE, TITANIUM DIOXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 4a233350-729a-1e0c-e063-6394a90ad48c | 2026-07-08 | Warnings | 15FIX9V2JP |
| SKIN-INFUSED FOUNDATION SPF 25- shade BB9 01 | ZINC OXIDE, TITANIUM DIOXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 4a23f72b-4c33-a100-e063-6294a90ac632 | 2026-07-08 | Warnings | 15FIX9V2JP |
| SKIN-INFUSED FOUNDATION SPF 25- shade BB10 01 | ZINC OXIDE, TITANIUM DIOXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 4a241d80-b9d2-ea93-e063-6294a90ab366 | 2026-07-08 | Warnings | 15FIX9V2JP |
| SKIN-INFUSED FOUNDATION SPF 25- shade BB8 01 | ZINC OXIDE, TITANIUM DIOXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 4a23f728-a824-48a6-e063-6394a90acae7 | 2026-07-08 | Warnings | 15FIX9V2JP |
| SKIN-INFUSED FOUNDATION SPF 25- shade BB4 01 | ZINC OXIDE, TITANIUM DIOXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 4a23653a-2481-bd15-e063-6394a90a7133 | 2026-07-08 | Warnings | 15FIX9V2JP |