Dexmethylphenidate Hydrochloride Extended-Release (dexmethylphenidate hydrochloride) by Sandoz Inc: new human prescription drug listing

Dexmethylphenidate Hydrochloride Extended-Release: new human prescription drug listing. Dated 42 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

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FieldValue
ProductDexmethylphenidate Hydrochloride Extended-Release
Generic namedexmethylphenidate hydrochloride
NDC0781-2730
LabelerSandoz Inc
Product typeHUMAN PRESCRIPTION DRUG
Approval pathwayNDA AUTHORIZED GENERIC
Application numberNDA021802
Dosage formCAPSULE, EXTENDED RELEASE
RouteORAL
Active ingredientsDEXMETHYLPHENIDATE HYDROCHLORIDE 20 mg/1
Marketing start2026-09-24
Package configurations1
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  • Source agency: U.S. FDA National Drug Code (NDC) Directory via openFDA
  • Record date: 2026-09-24
  • 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: Dexmethylphenidate Hydrochloride Extended-Release 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)

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65 / 100 Launch Signal Score

  • Prescription or biologic product.
  • New generic entry: wholesalers and GPOs re-bid contracts.

What is the FdaNdcDirectoryPulse record for Dexmethylphenidate Hydrochloride Extended-Release?

Dexmethylphenidate Hydrochloride Extended-Release by Sandoz Inc: new human prescription drug listing (NDA AUTHORIZED GENERIC) starting 2026-09-24.

How does Dexmethylphenidate Hydrochloride Extended-Release compare to other FdaNdcDirectoryPulse records?

It is 42 days old, still within a typical 45-day follow-up window.

Dexmethylphenidate Hydrochloride Extended-Release vs. top 3 peers

OrganizationLocationRecord date
Dexmethylphenidate Hydrochloride Extended-ReleaseHUMAN PRESCRIPTION DRUG2026-09-24
YESAFILIHUMAN PRESCRIPTION DRUG2026-11-03
LEROCHOLHUMAN PRESCRIPTION DRUG2026-11-01
CAMCEVI ETMHUMAN PRESCRIPTION DRUG2026-10-31

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FdaNdcDirectoryPulse: Prescription (Rx) FdaNdcDirectoryPulse: Authorized generic

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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.

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