Orange Book drug · Generic (ANDA)

Ampicillin Trihydrate

Ampicillin/ampicillin Trihydrate

ANDA 064082 2 strengths Sandoz

Approved

Aug 29, 1995

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Ampicillin Trihydrate?

Ampicillin Trihydrate contains Ampicillin/ampicillin Trihydrate and appears in 16 FDA Orange Book applications. ANDA 064082 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 064082
Lead application holder: Sandoz Inc
Product presentations: 2
Marketing categories: Discontinued and 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	EQ 250MG BASE	CAPSULEORAL	Discontinued	None posted	None posted
002	EQ 500MG BASE	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

Sandoz Inc

The Orange Book identifies this organization as the applicant responsible for ANDA 064082.

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

Status varies by presentation: 1 on the Discontinued Drug Product List and 1 prescription

Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.

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. 1 presentation in the application has no posted TE 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

18 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 064082 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

Ampicillin/ampicillin Trihydrate

22 applications

Product rows: 42
Active applications: 2
Active with AB row: 2

Polycillin · NDA 050310 Principen '250' · NDA 050056 Principen · ANDA 062888 Amcill · ANDA 062041

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue ANDA-064082

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 064082

Discontinued

Strength: EQ 250MG BASE
Dosage form: CAPSULE
Route: ORAL
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Aug 29, 1995
31 yr 4 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Strength

EQ 250MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 064082

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 Ampicillin Trihydrate

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 Ampicillin Trihydrate, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
ANDA 060765	Ivax Sub Teva Pharms	Approved Prior to Jan 1, 1982	2	—	Discontinued
ANDA 061370	Teva	Approved Prior to Jan 1, 1982	2	—	Discontinued
ANDA 061387	Vitarine	Approved Prior to Jan 1, 1982	2	—	Discontinued
ANDA 061502	Chartwell Rx	Approved Prior to Jan 1, 1982	2	—	Discontinued
ANDA 061601	Belcher Pharms	Approved Prior to Jan 1, 1982	2	—	Discontinued
ANDA 061602	Belcher Pharms	Approved Prior to Jan 1, 1982	2	—	Discontinued
ANDA 061755	Mylan	Approved Prior to Jan 1, 1982	2	—	Discontinued
ANDA 061829	Mylan	Approved Prior to Jan 1, 1982	2	—	Discontinued
ANDA 061853	Purepac Pharm	Approved Prior to Jan 1, 1982	2	—	Discontinued
ANDA 061980	Purepac Pharm	Approved Prior to Jan 1, 1982	2	—	Discontinued
ANDA 062208	Lederle	Approved Prior to Jan 1, 1982	2	—	Discontinued
ANDA 062882	Strides Pharma Intl	Feb 25, 1988	1	—	Discontinued
ANDA 062883	Strides Pharma Intl	Feb 25, 1988	1	—	Discontinued
ANDA 062982	Ph Health	Feb 10, 1989	2	—	Discontinued
ANDA 216554	Aurobindo Pharma	Oct 31, 2023	2	—	Prescription

Active-ingredient family

Brand + generics

Generic (ANDA) of Ampicillin/ampicillin Trihydrate

View full Ampicillin/ampicillin Trihydrate 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.