Orange Book drug · Generic (ANDA)

Olmesartan Medoxomil And Hydrochlorothiazide

Hydrochlorothiazide; Olmesartan Medoxomil

DiscontinuedANDA 078827 3 strengths Natco Pharma USA

Approved

Oct 26, 2016

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Olmesartan Medoxomil And Hydrochlorothiazide?

Olmesartan Medoxomil And Hydrochlorothiazide contains Hydrochlorothiazide; Olmesartan Medoxomil and appears in 16 FDA Orange Book applications. ANDA 078827 is the lead filing, with 3 presentations shown in detail; the other exact-name filings are listed separately. The page preserves strength, dosage form, route, status, RLD/RS, TE, patent, and exclusivity facts. Clinical labeling requires an exact application-matched source.

FDA applications: 16; lead ANDA 078827
Lead application holder: Natco Pharma USA LLC
Product presentations: 3
Marketing categories: Discontinued
Reference roles: None posted
TE codes: None posted
Listed patents: 0
Exclusivity records: 0

Sourced from the official FDA Orange Book data file · snapshot refreshed Jul 02, 2026, 06:34 PM

FDA product-presentation matrix

Every product number in this exact application

Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
Product	Strength	Dosage form / route	Marketing status	TE code	Reference role
001	12.5MG;20MG	TABLETORAL	Discontinued	None posted	None posted
002	12.5MG;40MG	TABLETORAL	Discontinued	None posted	None posted
003	25MG;40MG	TABLETORAL	Discontinued	None posted	None posted

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Natco Pharma USA LLC

The Orange Book identifies this organization as the applicant responsible for ANDA 078827.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not

FDA marketing status

3 presentations listed as on the Discontinued Drug Product List

A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

No listed patents or exclusivity records

This means none appear for this application in the current Orange Book files. It is not a freedom-to-operate opinion and does not rule out unlisted patents, regulatory barriers, or product-specific rights.

Same-ingredient landscape

0 other ANDAs and 1 other NDA found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

ANDA 078827 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet · Oral

Hydrochlorothiazide; Olmesartan Medoxomil

17 applications

Product rows: 51
Active applications: 13
Active with AB row: 13

Benicar HCT · NDA 021532

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue ANDA-078827

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

3 approved presentations · ANDA 078827

Discontinued

Strength: 12.5MG;20MG
Dosage form: TABLET
Route: ORAL
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Oct 26, 2016
9 yr 11 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Strength

12.5MG;20MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 078827

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Reference standard (RS)

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Other FDA applications for Olmesartan Medoxomil And Hydrochlorothiazide

15 additional filings · 15 generic

The FDA has approved 16 separate applications under this product name. Each row is one application: a distinct applicant and approval for the same drug.

Other FDA applications approved under the product name Olmesartan Medoxomil And Hydrochlorothiazide, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
ANDA 200532	Teva Pharms USA	Apr 24, 2017	3	—	Discontinued
ANDA 204233	Alembic	Apr 24, 2017	3	AB	Prescription
ANDA 204801	Macleods Pharms Ltd	Jun 01, 2023	3	AB	Prescription
ANDA 205391	Aurobindo Pharma	Apr 24, 2017	3	AB	Prescription
ANDA 206371	Micro Labs	Apr 13, 2026	3	AB	Prescription
ANDA 206377	Zydus Pharms	Feb 24, 2023	3	—	Discontinued
ANDA 206515	Torrent	May 03, 2017	3	—	Discontinued
ANDA 207037	Alkem Labs Ltd	Jul 11, 2024	3	AB	Prescription
ANDA 207804	Prinston Inc	Apr 24, 2017	3	AB	Prescription
ANDA 208465	Sciegen Pharms	Mar 31, 2026	3	AB	Prescription
ANDA 208847	Umedica	Sep 17, 2019	3	AB	Prescription
ANDA 209199	Hetero Labs Ltd V	Jul 25, 2025	3	AB	Prescription
ANDA 209281	Accord Hlthcare	Feb 07, 2019	3	AB	Prescription
ANDA 214427	Hangzhou Binjiang	Aug 20, 2025	3	AB	Prescription
ANDA 217398	Msn	Sep 26, 2025	3	AB	Prescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Hydrochlorothiazide; Olmesartan Medoxomil

Benicar HCTBrand (NDA)
NDA 021532 · Cosette
2003

View full Hydrochlorothiazide; Olmesartan Medoxomil family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.