Paroxetine
- Product NDC
- 55700-379
- 11-digit product format
- 557000379
- Labeler code
- 55700
- Product ID
- 55700-379_915a82be-a280-4e82-8efc-92023a7174fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paroxetine hydrochloride hemihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA203854
- Marketing category
- ANDA
- Marketing start
- 2014-11-01
- Marketing end
- 0000-00-00
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55700-379-30 | 2025-01-09 | C162847 | 48780-1 | f386c64a-22a2-0266-e053-dadaa90a7c1a | dc873d55-478d-454d-ba96-69daae82e1f1 |
| 55700-379-60 | 2025-01-09 | C162847 | 48780-1 | f386c64a-22a2-0266-e053-dadaa90a7c1a | dc873d55-478d-454d-ba96-69daae82e1f1 |
| 55700-379-90 | 2025-01-09 | C162847 | 48780-1 | f386c64a-22a2-0266-e053-dadaa90a7c1a | dc873d55-478d-454d-ba96-69daae82e1f1 |
| 55700-379-30 | 2023-01-30 | C162847 | 48780-1 | f386c64a-22a2-0266-e053-dadaa90a7c1a | dc873d55-478d-454d-ba96-69daae82e1f1 |
| 55700-379-60 | 2023-01-30 | C162847 | 48780-1 | f386c64a-22a2-0266-e053-dadaa90a7c1a | dc873d55-478d-454d-ba96-69daae82e1f1 |
| 55700-379-90 | 2023-01-30 | C162847 | 48780-1 | f386c64a-22a2-0266-e053-dadaa90a7c1a | dc873d55-478d-454d-ba96-69daae82e1f1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55700-379-30 | EA - Each | 55700-379 | 4ca7c007-b590-40fb-9502-d17e1967ef1b | 1 | 2016-10-06 |
| 55700-379-60 | EA - Each | 55700-379 | bf29e004-378b-4cad-a91a-a51b6a66658d | 1 | 2016-10-06 |
| 55700-379-90 | EA - Each | 55700-379 | 5439188b-9f24-4972-bc8a-e7585afcbe94 | 1 | 2016-10-06 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55700-379-30 | 55700037930 | 30 TABLET, FILM COATED in 1 BOTTLE (55700-379-30) | 2016-02-19 | 0000-00-00 | No | No | Current |
| 55700-379-60 | 55700037960 | 60 TABLET, FILM COATED in 1 BOTTLE (55700-379-60) | 2016-02-19 | 0000-00-00 | No | No | Current |