Norethindrone and ethinyl estradiol by Apotex Corp.: new human prescription drug listing

Norethindrone and ethinyl estradiol: new human prescription drug listing. Dated 25 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 10 published fields of this record are shown below. Locked: 499 related FdaNdcDirectoryPulse records and the 5-column CSV export.

FieldValue
ProductNorethindrone and ethinyl estradiol
Generic nameNorethindrone and ethinyl estradiol
NDC60505-4901
LabelerApotex Corp.
Product typeHUMAN PRESCRIPTION DRUG
Approval pathwayANDA
Application numberANDA206864
Dosage formKIT
Marketing start2026-10-10
Package configurations1
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  • Source agency: U.S. FDA National Drug Code (NDC) Directory via openFDA
  • Record date: 2026-10-10
  • 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: Norethindrone and ethinyl estradiol 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)

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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 Norethindrone and ethinyl estradiol?

Norethindrone and ethinyl estradiol by Apotex Corp.: new human prescription drug listing (ANDA) starting 2026-10-10.

How does Norethindrone and ethinyl estradiol compare to other FdaNdcDirectoryPulse records?

It is 25 days old, still within a typical 45-day follow-up window.

Norethindrone and ethinyl estradiol vs. top 3 peers

OrganizationLocationRecord date
Norethindrone and ethinyl estradiolHUMAN PRESCRIPTION DRUG2026-10-10
ENZEEVUHUMAN PRESCRIPTION DRUG2026-10-26
DaptomycinHUMAN PRESCRIPTION DRUG2026-10-22
TechneLiteHUMAN PRESCRIPTION DRUG2026-10-21

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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.

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