What is NDC 69452-437?

69452-437 is the product NDC for Nicardipine Hydrochloride, Nicardipine hydrochloride 30 mg/1 capsule, listed with the FDA by Bionpharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Bionpharma Inc., NDC labeler code 69452. 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 69452-437

NDC codes

FDA NDC Directory

Product NDC (as listed)69452-437Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69452-0437Add 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
69452-437-19	6945204371969452043719	90 CAPSULE in 1 BOTTLE, PLASTIC (69452-437-19)Marketed from Nov 4, 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 — 30 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Bionpharma Inc.NDC labeler code 69452
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217555
Marketing start: Nov 4, 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 69452-437_261ba7ea-d55b-1ba9-e063-6394a90a4c8cSPL ID 261ba7ea-d55b-1ba9-e063-6394a90a4c8cSPL set ID 7bed5d8c-30c2-4598-acf3-2edba825a56dRxCUI 858613, 858616UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469452043719 followed by a unit qualifier and the quantity

Package 69452-0437-19. 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 Nov 4, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE I. Stable Angina Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine it is important to be aware of the relatively large peak to trough differences in blood pressure effect (see DOSAGE AND ADMINISTRATION ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69452-437

What is NDC 69452-437?: 69452-437 is the product NDC for Nicardipine Hydrochloride, Nicardipine hydrochloride 30 mg/1 capsule, listed with the FDA by Bionpharma 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?: Bionpharma Inc., NDC labeler code 69452. 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 217555

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

FDA NDC Directory listings under ANDA 217555
Product	Strength	Form · route	Labeler	Product NDC
Nicardipine Hydrochloride	Nicardipine hydrochloride 20 mg/1	CapsuleOral	Bionpharma Inc.	69452-436