Ciprofloxacin and Dexamethasone by Alembic Pharmaceuticals Limited: new human prescription drug listing

Ciprofloxacin and Dexamethasone: new human prescription drug listing. Dated 21 days ago, it is in the active follow-up window. 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
ProductCiprofloxacin and Dexamethasone
Generic nameCiprofloxacin and Dexamethasone
NDC46708-776
LabelerAlembic Pharmaceuticals Limited
Product typeHUMAN PRESCRIPTION DRUG
Approval pathwayANDA
Application numberANDA217723
Dosage formSUSPENSION/ DROPS
RouteAURICULAR (OTIC)
Active ingredientsCIPROFLOXACIN HYDROCHLORIDE 3 mg/mL; DEXAMETHASONE 1 mg/mL
Marketing start2026-10-15
Package configurations1
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  • Source agency: U.S. FDA National Drug Code (NDC) Directory via openFDA
  • Record date: 2026-10-15
  • 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: Ciprofloxacin and Dexamethasone and 1,345 HUMAN PRESCRIPTION DRUG peers

  • HUMAN PRESCRIPTION DRUG FdaNdcDirectoryPulse records like this one: 1,345
  • Timing: Medium: dated in the last 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 Ciprofloxacin and Dexamethasone?

Ciprofloxacin and Dexamethasone by Alembic Pharmaceuticals Limited: new human prescription drug listing (ANDA) starting 2026-10-15.

How does Ciprofloxacin and Dexamethasone compare to other FdaNdcDirectoryPulse records?

It is 21 days old, still within a typical 45-day follow-up window.

Ciprofloxacin and Dexamethasone vs. top 3 peers

OrganizationLocationRecord date
Ciprofloxacin and DexamethasoneHUMAN PRESCRIPTION DRUG2026-10-15
YESAFILIHUMAN PRESCRIPTION DRUG2026-11-03
LEROCHOLHUMAN PRESCRIPTION DRUG2026-11-01
CAMCEVI ETMHUMAN PRESCRIPTION DRUG2026-10-31

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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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