Orange Book drug · Brand (NDA)

Normosol-r In Plastic Container

Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate

NDA 017586 Otsuka Icu Medcl

Approved

Prior to Jan 1, 1982

Strengths

Listed patents

What does the FDA Orange Book show for Normosol-r In Plastic Container?

Normosol-r In Plastic Container contains Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate and is the new drug FDA Orange Book record for NDA 017586. The application has 1 presentation 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 017586
Application holder: Otsuka Icu Medical LLC
Product presentations: 1
Marketing categories: Prescription
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	30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML	INJECTABLEINJECTION	Prescription	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

Otsuka Icu Medical LLC

The Orange Book identifies this organization as the applicant responsible for NDA 017586.

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

1 presentation 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

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

2 other ANDAs and 7 other NDAs found

1 of the related ANDA application is 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 017586 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Injectable · Injection

Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate

6 applications

Product rows: 7
Active applications: 4
Active with AB row: 0

Isolyte S In Plastic Container · NDA 019711 Isolyte S In Plastic Container · NDA 018252 Plasma-lyte 148 In Water In Plastic Container · NDA 017378 Multiple Electrolytes Injection Type 1 Usp Ph 5.5 · ANDA 215370 Multiple Electrolytes Injection Type 1 Usp Ph 7.4 · ANDA 215371

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-017586

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.

Product detail

NDA 017586

Strength: 30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML
Dosage form: INJECTABLE
Route: INJECTION
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

No patent or exclusivity dates are listed for this product.

Pharmaceutical detail

FDA product record

Active ingredient

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

Strength

30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 017586

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.

Active-ingredient family

Brand + generics

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

View full Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Gluconate 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.