Orange Book drug · Brand (NDA)

Cardene In 0.83% Sodium Chloride In Plastic Container

Nicardipine Hydrochloride

RLDNDA 019734 Chiesi

Approved

Nov 07, 2008

Strengths

Listed patents

What does the FDA Orange Book show for Cardene In 0.83% Sodium Chloride In Plastic Container?

Cardene In 0.83% Sodium Chloride In Plastic Container contains Nicardipine Hydrochloride and is the new drug FDA Orange Book record for NDA 019734. 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 019734
Application holder: Chiesi USA Inc
Product presentations: 1
Marketing categories: Prescription
Reference roles: RLD / RS
TE codes: AP
Listed patents: 6
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
004	40MG/200ML (0.2MG/ML)	INJECTABLEINTRAVENOUS	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

Chiesi USA Inc

The Orange Book identifies this organization as the applicant responsible for NDA 019734.

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

6 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Dec 26, 2027. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

24 other ANDAs and 4 other NDAs found

17 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 019734 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 Nicardipine Hydrochloride In 0.9% Sodium Chloride · ANDA 220243 Nicardipine Hydrochloride In 0.9% Sodium Chloride · ANDA 215592 Nicardipine Hydrochloride In 0.83% Sodium Chloride · ANDA 203978

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-019734

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 019734

TE APRLDRS

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.
Nov 07, 2008
18 yr ago
Today
Patent 10758616 expires
Listed drug product patent expiration.
Apr 18, 2027
in 9 mo
Patent 11547758 expires
Listed method-of-use patent (U-1029) expiration.
Apr 18, 2027
in 9 mo
Patent 7659291 expires
Listed method-of-use patent (U-1029) expiration.
Apr 18, 2027
in 9 mo
Patent 8455524 expires
Listed method-of-use patent (U-1029) expiration.
Apr 18, 2027
in 9 mo
Patent 7612102 expires
Listed drug product patent expiration.
Dec 26, 2027
in 1 yr 5 mo
Patent 9364564 expires
Listed drug product patent expiration.
Dec 26, 2027
in 1 yr 5 mo

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

NICARDIPINE HYDROCHLORIDE

Strength

40MG/200ML (0.2MG/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Application

NDA 019734

Product number

004

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
10758616	Apr 18, 2027	in 9 mo	Product
11547758	Apr 18, 2027	in 9 mo	U-1029
7659291	Apr 18, 2027	in 9 mo	U-1029
8455524	Apr 18, 2027	in 9 mo	U-1029
7612102	Dec 26, 2027	in 1 yr 5 mo	Product
9364564	Dec 26, 2027	in 1 yr 5 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 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.