Prescription drug · ANDA
Amlodipine and Olmesartan Medoxomil NDC 69238-2676
Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-2676-1 | 69238267601 | 1000 TABLET, FILM COATED in 1 BOTTLE (69238-2676-1)Marketed from Dec 3, 2018 |
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)
- Amlodipine and Olmesartan Medoxomil
- Generic name (nonproprietary)
- amlodipine and olmesartan medoxomil
- Active ingredients
- Amlodipine besylate — 5 mg/1Olmesartan medoxomil — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209010
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 69238-2676_31d0d1f2-a0c7-4cd3-80d2-d9f231687adcSPL ID 31d0d1f2-a0c7-4cd3-80d2-d9f231687adcSPL set ID 02f9b562-6f7f-4783-bb0d-67c318073e1cRxCUI 730861, 730866, 730869, 730872UNII 864V2Q084H, 6M97XTV3HDUPC 0369238267617, 0369238267518, 0369238267310, 0369238267419
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; 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
N469238267601followed by a unit qualifier and the quantityPackage 69238-2676-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 209010
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 |
|---|---|---|---|---|
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc | 50228-366 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc | 50228-365 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc | 50228-367 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc | 50228-368 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-2673 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-2674 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-2675 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-004 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-001 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-002 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-003 |