Orange Book drug · Brand (NDA)

Sodium Chloride 0.9% In Plastic Container

Sodium Chloride

RLDNDA 016366 Otsuka Icu Medcl

Approved

Prior to Jan 1, 1982

Strengths

Listed patents

Applications

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

Sodium Chloride 0.9% In Plastic Container contains Sodium Chloride and appears in 26 FDA Orange Book applications. NDA 016366 is the lead filing, with 1 presentation 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: 26; lead NDA 016366
Lead application holder: Otsuka Icu Medical LLC
Product presentations: 1
Marketing categories: Prescription
Reference roles: RLD / RS
TE codes: AP
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	900MG/100ML	INJECTABLEINJECTION	Prescription	AP	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

Otsuka Icu Medical LLC

The Orange Book identifies this organization as the applicant responsible for NDA 016366.

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

TE code AP across rated presentations

An AP 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

11 other ANDAs and 20 other NDAs found

9 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 016366 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

Sodium Chloride

23 applications

Product rows: 33
Active applications: 18
Active with AB row: 0

Sodium Chloride 0.9% · NDA 202832 Sodium Chloride 0.45% In Plastic Container · NDA 019759 Sodium Chloride 0.45% In Plastic Container · NDA 019635 Sodium Chloride 23.4% In Plastic Container · NDA 019329 Sodium Chloride 3% In Plastic Container · NDA 019022 Sodium Chloride · NDA 017013

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-016366

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 016366

TE APRLDRS

Strength: 900MG/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

SODIUM CHLORIDE

Strength

900MG/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Application

NDA 016366

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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 Sodium Chloride 0.9% In Plastic Container

25 additional filings · 9 generic

The FDA has approved 26 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 Sodium Chloride 0.9% In Plastic Container, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
NDA 016677	Baxter Hlthcare	Oct 30, 1985	3	—	Prescription
NDA 016733	B Braun	Approved Prior to Jan 1, 1982	1	AT	Prescription
NDA 017464	B Braun	Approved Prior to Jan 1, 1982	1	AP	Prescription
NDA 017514	Otsuka Icu Medcl	Approved Prior to Jan 1, 1982	1	AT	Prescription
NDA 018803	Hospira	Oct 29, 1982	6	AP	Prescription
NDA 019217	Icu Medical Inc	Nov 18, 1998	3	—	Discontinued
NDA 019465	Hospira	Jul 15, 1985	2	AP	Prescription
NDA 019480	Hospira	Sep 17, 1985	1	AP	Prescription
NDA 019635	B Braun	Mar 09, 1988	1	AP	Prescription
NDA 020178	Baxter Hlthcare	Dec 07, 1992	2	AP	Prescription
NDA 021569	Liebel-flarsheim	Jul 27, 2006	2	—	Prescription
ANDA 077407	Taro	Aug 11, 2006	2	AP	Prescription
ANDA 088912	Fresenius Kabi USA	Nov 29, 1985	4	—	Prescription
NDA 017427	Baxter Hlthcare	Approved Prior to Jan 1, 1982	1	AT	Prescription
NDA 017867	Baxter Hlthcare	Approved Prior to Jan 1, 1982	1	AT	Prescription
NDA 018314	Otsuka Icu Medcl	Approved Prior to Jan 1, 1982	1	AT	Prescription
NDA 018502	Miles	Approved Prior to Jan 1, 1982	2	—	Discontinued
NDA 019218	Abbott	Jul 13, 1984	2	—	Discontinued
ANDA 076316	Gvs Tm	Oct 27, 2004	1	AP	Prescription
ANDA 078177	Fresenius Medcl	Apr 12, 2007	1	AP	Prescription
ANDA 203352	Jubilant Cadista	May 18, 2016	2	—	Discontinued
ANDA 207310	Fresenius Kabi USA	Sep 19, 2017	1	AP	Prescription
ANDA 207956	Laboratorios Grifols	May 25, 2017	1	AP	Prescription
ANDA 211968	Nephron	Apr 23, 2020	2	AP	Prescription
ANDA 213688	Fresenius Kabi USA	Jun 24, 2024	1	AT	Prescription

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 Sodium Chloride 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.