Prescription drug · ANDA
Nicardipine hydrochloride (Nicardipine) NDC 69238-2692
Nicardipine hydrochloride 30 mg/1 · Capsule · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-2692-1 | 69238269201 | 90 CAPSULE in 1 BOTTLE (69238-2692-1)Marketed from Oct 3, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Active ingredients
- Nicardipine hydrochloride — 30 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218202
- Marketing start
- Listing expires
- 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 69238-2692_8f57d96f-7e5b-409f-9e21-c3ed67369716SPL ID 8f57d96f-7e5b-409f-9e21-c3ed67369716SPL set ID 79304b0f-53d3-4065-8c81-7031d1141694RxCUI 858613, 858616UNII K5BC5011K3UPC 0369238269215, 0369238269116
- 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
N469238269201followed by a unit qualifier and the quantityPackage 69238-2692-01. 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 .
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.
About NDC 69238-2692
- What is NDC 69238-2692?
- 69238-2692 is the product NDC for Nicardipine hydrochloride (nicardipine), Nicardipine hydrochloride 30 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nicardipine hydrochloride (Nicardipine).
- What is the active ingredient?
- Nicardipine hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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.
Related NDCs: other Nicardipine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 218202
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nicardipine hydrochloridenicardipine | Nicardipine hydrochloride 20 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-2691 |