What is NDC 65219-818?

65219-818 is the product NDC for Nicardipine Hydrochloride, Nicardipine hydrochloride 25 mg/10mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nicardipine Hydrochloride?

42 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nicardipine Hydrochloride NDC 65219-818

NDC codes

FDA NDC Directory

Product NDC (as listed)65219-818Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65219-0818Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
65219-818-10	65219081810	1 VIAL, GLASS in 1 CARTON (65219-818-10) / 10 mL in 1 VIAL, GLASSMarketed from Sep 11, 2024
65219-818-13	65219081813	10 VIAL, GLASS in 1 CARTON (65219-818-13) / 10 mL in 1 VIAL, GLASS (65219-818-03)Marketed from Nov 17, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Nicardipine Hydrochloride
Generic name (nonproprietary): nicardipine hydrochloride
Active ingredients: Nicardipine hydrochloride — 25 mg/10mL
Dosage form: Injection
Route: Intravenous
Labeler: Fresenius Kabi USA, LLCNDC labeler code 65219
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217548
Marketing start: Sep 11, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 65219-818_457af9c7-009c-4323-88fb-eb3b3a8e4b62SPL ID 457af9c7-009c-4323-88fb-eb3b3a8e4b62SPL set ID cdafe6cc-b03e-4e72-9d0a-6baa977149d6RxCUI 858607UNII K5BC5011K3
Pharmacologic class: Dihydropyridine Calcium Channel Blocker

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N465219081810 followed by a unit qualifier and the quantity

Package 65219-0818-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 6, 2026.

Indications (excerpt from the label)

Nicardipine hydrochloride injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible. ( 1 ) 1.1 Hypertension Nicardipine hydrochloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.6) ].

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65219-818

What is NDC 65219-818?: 65219-818 is the product NDC for Nicardipine Hydrochloride, Nicardipine hydrochloride 25 mg/10mL injection, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nicardipine Hydrochloride.
What is the active ingredient?: Nicardipine hydrochloride.
Who is the labeler?: Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nicardipine Hydrochloride?: 42 other product NDCs are listed under this name. See all Nicardipine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nicardipine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nicardipine Hydrochloride	Nicardipine hydrochloride 20 mg/1	CapsuleOral	Amerisyn LLC	87564-027	87564-0027-90
Nicardipine Hydrochloride	Nicardipine hydrochloride 30 mg/1	CapsuleOral	Amerisyn LLC	87564-028	87564-0028-90
Nicardipine Hydrochloride	Nicardipine hydrochloride .2 mg/mL	InjectionIntravenous	Caplin Steriles Limited	65145-198	65145-0198-10
Nicardipine Hydrochloride	Nicardipine hydrochloride .1 mg/mL	InjectionIntravenous	Caplin Steriles Limited	65145-197	65145-0197-10
Nicardipine Hydrochloride	Nicardipine hydrochloride .2 mg/mL	InjectionIntravenous	Somerset Therapeutics, LLC	70069-876	70069-0876-10
Nicardipine Hydrochloride	Nicardipine hydrochloride .1 mg/mL	InjectionIntravenous	Somerset Therapeutics, LLC	70069-875	70069-0875-10
Nicardipine hydrochloride	Nicardipine hydrochloride 2.5 mg/mL	InjectionIntravenous	Lifestar Pharma LLC	70756-686	70756-0686-10
Nicardipine Hydrochloride	Nicardipine hydrochloride 30 mg/1	CapsuleOral	Amici Pharma Inc	69292-621	69292-0621-90
Nicardipine Hydrochloride	Nicardipine hydrochloride 20 mg/1	CapsuleOral	Amici Pharma Inc	69292-620	69292-0620-90
Nicardipine Hydrochloride	Nicardipine hydrochloride 2.5 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-333	25021-0333-10

All 43 Nicardipine Hydrochloride NDCs

Other NDCs under ANDA 217548

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 217548
Product	Strength	Form · route	Labeler	Product NDC
Nicardipine Hydrochloride	Nicardipine hydrochloride 25 mg/10mL	InjectionIntravenous	Chengdu Shuode Pharmaceutical Co., Ltd	82432-103