Orange Book drug · Brand (NDA)

Micafungin In Sodium Chloride 0.9%

Micafungin Sodium

RLDNDA 216142 3 strengths Baxter Hlthcare Corp

Approved

Sep 29, 2023

Strengths

Listed patents

What does the FDA Orange Book show for Micafungin In Sodium Chloride 0.9%?

Micafungin In Sodium Chloride 0.9% contains Micafungin Sodium and is the new drug FDA Orange Book record for NDA 216142. The application has 3 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application: NDA 216142
Application holder: Baxter Healthcare Corp
Product presentations: 3
Marketing categories: Prescription
Reference roles: RLD / RS
TE codes: None posted
Listed patents: 1
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 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTIONINTRAVENOUS	Prescription	None posted	RLDRS
002	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTIONINTRAVENOUS	Prescription	None posted	RLDRS
003	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTIONINTRAVENOUS	Prescription	None posted	RLDRS

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

Baxter Healthcare Corp

The Orange Book identifies this organization as the applicant responsible for NDA 216142.

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 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

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

1 listed patent expiration and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Dec 15, 2037. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

12 other ANDAs and 3 other NDAs found

11 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

NDA 216142 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Solution · Intravenous

Micafungin Sodium

1 application

Product rows: 3
Active applications: 1
Active with AB row: 0

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-216142

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 · NDA 216142

RLDRS

Strength: EQ 50MG BASE/50ML (EQ 1MG BASE/ML)
Dosage form: SOLUTION
Route: INTRAVENOUS
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Sep 29, 2023
2 yr 10 mo ago
Today
Patent 12403173 expires
Listed drug product patent expiration.
Dec 15, 2037
in 11 yr 7 mo

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

MICAFUNGIN SODIUM

Strength

EQ 50MG BASE/50ML (EQ 1MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 216142

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12403173	Dec 15, 2037	in 11 yr 7 mo	Product

RLDRS

Strength: EQ 100MG BASE/100ML (EQ 1MG BASE/ML)
Dosage form: SOLUTION
Route: INTRAVENOUS
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Sep 29, 2023
2 yr 10 mo ago
Today
Patent 12403173 expires
Listed drug product patent expiration.
Dec 15, 2037
in 11 yr 7 mo

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

MICAFUNGIN SODIUM

Strength

EQ 100MG BASE/100ML (EQ 1MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 216142

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12403173	Dec 15, 2037	in 11 yr 7 mo	Product

RLDRS

Strength: EQ 150MG BASE/150ML (EQ 1MG BASE/ML)
Dosage form: SOLUTION
Route: INTRAVENOUS
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Sep 29, 2023
2 yr 10 mo ago
Today
Patent 12403173 expires
Listed drug product patent expiration.
Dec 15, 2037
in 11 yr 7 mo

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

MICAFUNGIN SODIUM

Strength

EQ 150MG BASE/150ML (EQ 1MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 216142

Product number

003

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12403173	Dec 15, 2037	in 11 yr 7 mo	Product

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Micafungin Sodium 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.