OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE (Olmesartan medoxomil and hydrocholorothiazide) by Micro Labs Limited: new human prescription drug listing

OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE: new human prescription drug listing. Dated 20 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

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FieldValue
ProductOLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE
Generic nameOlmesartan medoxomil and hydrocholorothiazide
NDC42571-204
LabelerMicro Labs Limited
Product typeHUMAN PRESCRIPTION DRUG
Approval pathwayANDA
Application numberANDA206371
Dosage formTABLET, FILM COATED
RouteORAL
Active ingredientsOLMESARTAN MEDOXOMIL 20 mg/1; HYDROCHLOROTHIAZIDE 12.5 mg/1
Marketing start2026-10-15
Package configurations4
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  • Source agency: U.S. FDA National Drug Code (NDC) Directory via openFDA
  • Record date: 2026-10-15
  • Data refreshed: 2026-11-03
  • 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: OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE 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 OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE?

OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE by Micro Labs Limited: new human prescription drug listing (ANDA) starting 2026-10-15.

How does OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE compare to other FdaNdcDirectoryPulse records?

It is 20 days old, still within a typical 45-day follow-up window.

OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDE vs. top 3 peers

OrganizationLocationRecord date
OLMESARTAN MEDOXOMIL and HYDROCHOLOROTHIAZIDEHUMAN PRESCRIPTION DRUG2026-10-15
ENZEEVUHUMAN PRESCRIPTION DRUG2026-10-26
DaptomycinHUMAN PRESCRIPTION DRUG2026-10-22
TechneLiteHUMAN PRESCRIPTION DRUG2026-10-21

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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.

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