Quetiapine fumarate
- Product NDC
- 57297-446
- 11-digit product format
- 572970446
- Labeler code
- 57297
- Product ID
- 57297-446_28b08037-0fdb-4dd9-a3e4-e9bba5ca8948
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- LUPIN LIMITED
- Application
- ANDA201109
- Marketing category
- ANDA
- Marketing start
- 2012-03-27
- Marketing end
- 0000-00-00
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57297-446-01 | 2024-12-19 | C162847 | 48780-1 | 9d75b9d1-0e8e-f424-e053-dadaa90a57ce | b519b924-2348-46ac-b9a2-c9c198257ea4 |
| 57297-446-03 | 2024-12-19 | C162847 | 48780-1 | 9d75b9d1-0e8e-f424-e053-dadaa90a57ce | b519b924-2348-46ac-b9a2-c9c198257ea4 |
| 57297-446-13 | 2024-12-19 | C162847 | 48780-1 | 9d75b9d1-0e8e-f424-e053-dadaa90a57ce | b519b924-2348-46ac-b9a2-c9c198257ea4 |
| 57297-446-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0e8e-f424-e053-dadaa90a57ce | b519b924-2348-46ac-b9a2-c9c198257ea4 |
| 57297-446-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0e8e-f424-e053-dadaa90a57ce | b519b924-2348-46ac-b9a2-c9c198257ea4 |
| 57297-446-13 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0e8e-f424-e053-dadaa90a57ce | b519b924-2348-46ac-b9a2-c9c198257ea4 |