Prescription drug · ANDA
Isradipine NDC 42291-062
Isradipine 2.5 mg/1 · Capsule · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-062-01 | 42291006201 | 100 CAPSULE in 1 BOTTLE (42291-062-01)Marketed from Jun 9, 2023 |
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)
- Isradipine
- Generic name (nonproprietary)
- isradipine
- Active ingredients
- Isradipine — 2.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- AvKARENDC labeler code 42291
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077317
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 42291-062_485b4749-5065-6c1c-e063-6294a90ade38SPL ID 485b4749-5065-6c1c-e063-6294a90ade38SPL set ID fdb4c50e-6e6f-a43d-e053-6294a90aa24fRxCUI 197848UNII YO1UK1S598UPC 0342291062016
- 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
N442291006201followed by a unit qualifier and the quantityPackage 42291-0062-01. 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 Hypertension Isradipine is indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.
Excerpt only. Read the full label for complete information.
About NDC 42291-062
- What is NDC 42291-062?
- 42291-062 is the product NDC for Isradipine, Isradipine 2.5 mg/1 capsule, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Isradipine.
- What is the active ingredient?
- Isradipine.
- Who is the labeler?
- AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Isradipine?
- 4 other product NDCs are listed under this name. See all Isradipine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Isradipine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Isradipine | Isradipine 2.5 mg/1 | CapsuleOral | Elite Laboratories, Inc. | 64850-910 | 64850-0910-0164850-0910-05 |
| Isradipine | Isradipine 5 mg/1 | CapsuleOral | Elite Laboratories, Inc. | 64850-911 | 64850-0911-0164850-0911-05 |
| Isradipine | Isradipine 5 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 16252-540 | 16252-0540-01 |
| Isradipine | Isradipine 2.5 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 16252-539 | 16252-0539-01 |
Other NDCs under ANDA 077317
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 |
|---|---|---|---|---|
| Isradipine | Isradipine 2.5 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 16252-539 |
| Isradipine | Isradipine 5 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 16252-540 |