Orange Book drug · Generic (ANDA)

Omeprazole And Sodium Bicarbonate

Omeprazole; Sodium Bicarbonate

ANDA 204228 2 strengths Ajanta Pharma Ltd

Approved

Jul 15, 2016

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Omeprazole And Sodium Bicarbonate?

Omeprazole And Sodium Bicarbonate contains Omeprazole; Sodium Bicarbonate and appears in 16 FDA Orange Book applications. ANDA 204228 is the lead filing, with 2 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 204228
Lead application holder: Ajanta Pharma Ltd
Product presentations: 2
Marketing categories: Prescription
Reference roles: RS
TE codes: AB
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	20MG;1.1GM	CAPSULEORAL	Prescription	AB	None posted
002	40MG;1.1GM	CAPSULEORAL	Prescription	AB	RS

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

Ajanta Pharma Ltd

The Orange Book identifies this organization as the applicant responsible for ANDA 204228.

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

2 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

TE code AB across rated presentations

An AB code is an A-rating: FDA considers the product therapeutically equivalent to pharmaceutical equivalents in the same Orange Book heading and equivalence group.

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 5 other NDAs 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 204228 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Capsule · Oral

Omeprazole; Sodium Bicarbonate

14 applications

Product rows: 22
Active applications: 10
Active with AB row: 6

Zegerid Otc · NDA 022281 Zegerid · NDA 021849

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue ANDA-204228

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

2 approved presentations · ANDA 204228

TE AB

Strength: 20MG;1.1GM
Dosage form: CAPSULE
Route: ORAL
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Jul 15, 2016
10 yr 2 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Strength

20MG;1.1GM

Dosage form

CAPSULE

Route

ORAL

TE code

Application

ANDA 204228

Product number

001

Marketing status

Prescription

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 Omeprazole And Sodium Bicarbonate

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 Omeprazole And Sodium Bicarbonate, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
ANDA 205545	Ajanta Pharma Ltd	Jul 27, 2016	2	AB	Prescription
ANDA 078966	Strides Pharma Intl	May 25, 2010	2	—	Discontinued
ANDA 079182	Strides Pharma Intl	Apr 19, 2013	2	AB	Prescription
ANDA 201361	Perrigo R And D	Jul 15, 2016	1	—	Over-the-counter
ANDA 201946	Strides Pharma Intl	Jul 15, 2016	1	—	Discontinued
ANDA 203290	Zydus Pharms	May 25, 2018	2	AB	Prescription
ANDA 203345	Zydus	Mar 16, 2018	1	—	Over-the-counter
ANDA 204068	DR Reddys	Jul 15, 2016	2	AB	Prescription
ANDA 204137	Chartwell Rx	Jul 15, 2016	1	—	Discontinued
ANDA 204922	Aurolife Pharma LLC	Aug 19, 2016	2	AB	Prescription
ANDA 204923	Aurobindo Pharma	Nov 07, 2016	1	—	Over-the-counter
ANDA 207476	Sciegen Pharms	Dec 06, 2016	2	AB	Prescription
ANDA 212587	Anda Repository	Apr 30, 2020	2	AB	Prescription
ANDA 217784	DR Reddys	May 09, 2024	1	—	Over-the-counter
ANDA 219161	Novitium Pharma	Dec 10, 2025	2	AB	Prescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Omeprazole; Sodium Bicarbonate

View full Omeprazole; Sodium Bicarbonate 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.