What is NDC 72485-116?

72485-116 is the product NDC for Nicardipine Hydrochloride, Nicardipine hydrochloride 25 mg/10mL injection, listed with the FDA by Armas Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Armas Pharmaceuticals Inc., NDC labeler code 72485. 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?

43 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 72485-116

NDC codes

FDA NDC Directory

Product NDC (as listed)72485-116Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72485-0116Add 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
72485-116-10	7248501161072485011610	10 VIAL in 1 CARTON (72485-116-10) / 10 mL in 1 VIAL (72485-116-01)Marketed from Apr 3, 2024

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: Armas Pharmaceuticals Inc.NDC labeler code 72485
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216420
Marketing start: Apr 3, 2024
Listing expires: Dec 31, 2026
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 72485-116_a935edd9-4154-42a4-b769-0824200959e7SPL ID a935edd9-4154-42a4-b769-0824200959e7SPL set ID 7226a518-164b-4755-9624-1cc75c939063RxCUI 858607UNII K5BC5011K3UPC 0372485116010
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

N472485011610 followed by a unit qualifier and the quantity

Package 72485-0116-10. 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 Apr 4, 2024.

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 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 72485-116

What is NDC 72485-116?: 72485-116 is the product NDC for Nicardipine Hydrochloride, Nicardipine hydrochloride 25 mg/10mL injection, listed with the FDA by Armas Pharmaceuticals Inc.. It has 1 package NDC, 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?: Armas Pharmaceuticals Inc., NDC labeler code 72485. 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?: 43 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 .1 mg/mL	InjectionIntravenous	Fresenius Kabi USA, LLC	65219-296	65219-0296-20
Nicardipine Hydrochloride	Nicardipine hydrochloride .2 mg/mL	InjectionIntravenous	Fresenius Kabi USA, LLC	65219-298	65219-0298-20
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 .1 mg/mL	InjectionIntravenous	Caplin Steriles Limited	65145-197	65145-0197-10
Nicardipine Hydrochloride	Nicardipine hydrochloride .2 mg/mL	InjectionIntravenous	Caplin Steriles Limited	65145-198	65145-0198-10
Nicardipine Hydrochloride	Nicardipine hydrochloride .1 mg/mL	InjectionIntravenous	Somerset Therapeutics, LLC	70069-875	70069-0875-10
Nicardipine Hydrochloride	Nicardipine hydrochloride .2 mg/mL	InjectionIntravenous	Somerset Therapeutics, LLC	70069-876	70069-0876-10
Nicardipine hydrochloride	Nicardipine hydrochloride 2.5 mg/mL	InjectionIntravenous	Lifestar Pharma LLC	70756-686	70756-0686-10
Nicardipine Hydrochloride	Nicardipine hydrochloride 20 mg/1	CapsuleOral	Amici Pharma Inc	69292-620	69292-0620-90

All 44 Nicardipine Hydrochloride NDCs

Other NDCs under ANDA 216420

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

FDA NDC Directory listings under ANDA 216420
Product	Strength	Form · route	Labeler	Product NDC
Nicardipine Hydrochloride	Nicardipine hydrochloride 2.5 mg/mL	InjectionIntravenous	Micro Labs Limited	42571-394