Orange Book drug · Brand (NDA)

Lactated Ringer's In Plastic Container

Calcium Chloride; Potassium Chloride; Sodium Chloride; Sodium Lactate

RLDNDA 016682 Baxter Hlthcare

Approved

Prior to Jan 1, 1982

Strengths

Listed patents

Applications

What does the FDA Orange Book show for Lactated Ringer's In Plastic Container?

Lactated Ringer's In Plastic Container contains Calcium Chloride; Potassium Chloride; Sodium Chloride; Sodium Lactate across 12 FDA applications. NDA 016682 is the lead filing; other filings are listed separately. This page preserves Orange Book facts and source limits. Clinical labeling requires an exact application-matched source.

FDA applications: 12; lead NDA 016682
Lead application holder: Baxter Healthcare Corp
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	20MG/100ML;30MG/100ML;600MG/100ML;310MG/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

Baxter Healthcare Corp

The Orange Book identifies this organization as the applicant responsible for NDA 016682.

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

0 other ANDAs and 0 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

NDA 016682 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

Calcium Chloride; Potassium Chloride; Sodium Chloride; Sodium Lactate

7 applications

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

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-016682

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 016682

TE APRLDRS

Strength: 20MG/100ML;30MG/100ML;600MG/100ML;310MG/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

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

Strength

20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Application

NDA 016682

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 Lactated Ringer's In Plastic Container

11 additional filings · 1 generic

The FDA has approved 12 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 Lactated Ringer's In Plastic Container, with applicant, approval date, number of strengths, therapeutic-equivalence code, and marketing status.
Application	Applicant	Approved	Strengths	TE code	Status
NDA 018681	B Braun	Dec 27, 1982	1	AT	Prescription
NDA 018921	Baxter Hlthcare	Apr 03, 1984	1	AT	Prescription
NDA 019416	Otsuka Icu Medcl	Jan 17, 1986	1	AT	Prescription
NDA 017641	Otsuka Icu Medcl	Approved Prior to Jan 1, 1982	1	AP	Prescription
NDA 018023	B Braun	Approved Prior to Jan 1, 1982	1	—	Discontinued
NDA 018417	Miles	Approved Prior to Jan 1, 1982	1	—	Discontinued
NDA 018494	Baxter Hlthcare	Feb 19, 1982	1	AT	Prescription
NDA 019485	Abbott	Oct 24, 1985	1	—	Discontinued
NDA 019632	B Braun	Feb 29, 1988	1	AP	Prescription
NDA 019933	Baxter Hlthcare	Aug 29, 1989	1	—	Discontinued
ANDA 209338	Fresenius Kabi USA	Jan 28, 2019	1	AP	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.

No other applications share this active ingredient.

View full Calcium Chloride; Potassium Chloride; Sodium Chloride; Sodium Lactate 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.