Quetiapine Extended Release (Quetiapine) by REMEDYREPACK INC.: new human prescription drug listing
Quetiapine Extended Release: new human prescription drug listing. Dated 27 days ago, it is in the active follow-up window. Score 65/100. As of 2026-11-03, from U.S. FDA National Drug Code (NDC) Directory via openFDA.
Data as of · Compiled by Zalwin from U.S. FDA National Drug Code (NDC) Directory via openFDA
Free preview: all 12 published fields of this record are shown below. Locked: 499 related FdaNdcDirectoryPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Product | Quetiapine Extended Release |
| Generic name | Quetiapine |
| NDC | 70518-4769 |
| Labeler | REMEDYREPACK INC. |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | ANDA |
| Application number | ANDA209635 |
| Dosage form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active ingredients | QUETIAPINE FUMARATE 300 mg/1 |
| Marketing start | 2026-10-08 |
| Package configurations | 1 |
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- Source agency: U.S. FDA National Drug Code (NDC) Directory via openFDA
- Record date: 2026-10-08
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA National Drug Code (NDC) Directory via openFDA · Last refreshed: Tue, 03 Nov 2026 18:09:00 GMT
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Peer benchmark and outreach value: Quetiapine Extended Release and 1,241 HUMAN PRESCRIPTION DRUG peers
- HUMAN PRESCRIPTION DRUG FdaNdcDirectoryPulse records like this one: 1,241
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every HUMAN PRESCRIPTION DRUG peer: $248,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
65 / 100 Launch Signal Score
- Prescription or biologic product.
- New generic entry: wholesalers and GPOs re-bid contracts.
What is the FdaNdcDirectoryPulse record for Quetiapine Extended Release?
Quetiapine Extended Release by REMEDYREPACK INC.: new human prescription drug listing (ANDA) starting 2026-10-08.
How does Quetiapine Extended Release compare to other FdaNdcDirectoryPulse records?
It is 27 days old, still within a typical 45-day follow-up window.
Quetiapine Extended Release vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Quetiapine Extended Release | HUMAN PRESCRIPTION DRUG | 2026-10-08 |
| ENZEEVU | HUMAN PRESCRIPTION DRUG | 2026-10-26 |
| Daptomycin | HUMAN PRESCRIPTION DRUG | 2026-10-22 |
| TechneLite | HUMAN PRESCRIPTION DRUG | 2026-10-21 |
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Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.