Orange Book drug · Generic (ANDA)

Nicardipine Hydrochloride In 0.83% Sodium Chloride

Nicardipine Hydrochloride

ANDA 203978 Inforlife

Approved

Apr 17, 2024

Strengths

Listed patents

What does the FDA Orange Book show for Nicardipine Hydrochloride In 0.83% Sodium Chloride?

Nicardipine Hydrochloride In 0.83% Sodium Chloride contains Nicardipine Hydrochloride and is the generic drug FDA Orange Book record for ANDA 203978. 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: ANDA 203978
Application holder: Inforlife Sa
Product presentations: 1
Marketing categories: Prescription
Reference roles: None posted
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
002	40MG/200ML (0.2MG/ML)	INJECTABLEINTRAVENOUS	Prescription	AP	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

Inforlife Sa

The Orange Book identifies this organization as the applicant responsible for ANDA 203978.

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

23 other ANDAs and 5 other NDAs found

16 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 203978 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 · Intravenous

Nicardipine Hydrochloride

5 applications

Product rows: 12
Active applications: 5
Active with AB row: 0

Nicardipine Hydrochloride In 0.9% Sodium Chloride · NDA 022276 Cardene In 0.83% Sodium Chloride In Plastic Container · NDA 019734 Nicardipine Hydrochloride In 0.9% Sodium Chloride · ANDA 220243 Nicardipine Hydrochloride In 0.9% Sodium Chloride · ANDA 215592

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue ANDA-203978

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

ANDA 203978

TE AP

Strength: 40MG/200ML (0.2MG/ML)
Dosage form: INJECTABLE
Route: INTRAVENOUS
Marketing status: Prescription

Key dates

Approval, patents, exclusivity

Approval
FDA approval date of this drug product.
Apr 17, 2024
2 yr 4 mo ago
Today

Pharmaceutical detail

FDA product record

Active ingredient

NICARDIPINE HYDROCHLORIDE

Strength

40MG/200ML (0.2MG/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Application

ANDA 203978

Product number

002

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

Generic (ANDA) of Nicardipine Hydrochloride

View full Nicardipine Hydrochloride 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.