Dapagliflozin and Metformin Hydrochloride by Micro Labs Limited: new human prescription drug listing
Dapagliflozin and Metformin Hydrochloride: new human prescription drug listing. Dated 35 days ago, it serves as a historical benchmark. Score 65/100. As of 2026-11-04, 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 | Dapagliflozin and Metformin Hydrochloride |
| Generic name | Dapagliflozin and Metformin Hydrochloride |
| NDC | 42571-320 |
| Labeler | Micro Labs Limited |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | ANDA |
| Application number | ANDA211466 |
| Dosage form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active ingredients | DAPAGLIFLOZIN 5 mg/1; METFORMIN HYDROCHLORIDE 500 mg/1 |
| Marketing start | 2026-10-01 |
| Package configurations | 3 |
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- Source agency: U.S. FDA National Drug Code (NDC) Directory via openFDA
- Record date: 2026-10-01
- Data refreshed: 2026-11-04
- 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: Wed, 04 Nov 2026 18:12:05 GMT
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Peer benchmark and outreach value: Dapagliflozin and Metformin Hydrochloride and 1,345 HUMAN PRESCRIPTION DRUG peers
- HUMAN PRESCRIPTION DRUG FdaNdcDirectoryPulse records like this one: 1,345
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every HUMAN PRESCRIPTION DRUG peer: $269,000 (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 Dapagliflozin and Metformin Hydrochloride?
Dapagliflozin and Metformin Hydrochloride by Micro Labs Limited: new human prescription drug listing (ANDA) starting 2026-10-01.
How does Dapagliflozin and Metformin Hydrochloride compare to other FdaNdcDirectoryPulse records?
It is 35 days old, still within a typical 45-day follow-up window.
Dapagliflozin and Metformin Hydrochloride vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Dapagliflozin and Metformin Hydrochloride | HUMAN PRESCRIPTION DRUG | 2026-10-01 |
| YESAFILI | HUMAN PRESCRIPTION DRUG | 2026-11-03 |
| LEROCHOL | HUMAN PRESCRIPTION DRUG | 2026-11-01 |
| CAMCEVI ETM | HUMAN PRESCRIPTION DRUG | 2026-10-31 |
Related records
FdaNdcDirectoryPulse: Prescription (Rx) FdaNdcDirectoryPulse: Generic (ANDA)
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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.