Prescription drug · ANDA
Amlodipine and Olmesartan Medoxomil NDC 50228-365
Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 · Tablet, Film coated · Oral · ScieGen Pharmaceuticals, Inc
NDC codes
FDA NDC DirectoryProduct NDC (as listed)50228-365Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50228-0365Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-365-10 | 5022803651050228036510 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-365-10)Marketed from Dec 3, 2018 | |
| 50228-365-30 | 5022803653050228036530 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-365-30)Marketed from Dec 3, 2018 | |
| 50228-365-90 | 5022803659050228036590 | 90 TABLET, FILM COATED in 1 BOTTLE (50228-365-90)Marketed from Dec 3, 2018 |
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)
- Amlodipine and Olmesartan Medoxomil
- Generic name (nonproprietary)
- amlodipine and olmesartan medoxomil
- Active ingredients
- Amlodipine besylate — 5 mg/1Olmesartan medoxomil — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals, IncNDC labeler code 50228
- 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 50228-365_4e4a6a1a-6729-40b4-be88-43b1a11fcd24SPL ID 4e4a6a1a-6729-40b4-be88-43b1a11fcd24
- 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
N450228036510followed by a unit qualifier and the quantityPackage 50228-0365-10. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 50228-365
- What is NDC 50228-365?
- 50228-365 is the product NDC for Amlodipine and Olmesartan Medoxomil, Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 tablet, film coated, listed with the FDA by ScieGen Pharmaceuticals, Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amlodipine and Olmesartan Medoxomil.
- What is the active ingredient?
- Amlodipine besylate, Olmesartan medoxomil.
- Who is the labeler?
- ScieGen Pharmaceuticals, Inc, NDC labeler code 50228. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amlodipine and Olmesartan Medoxomil?
- 37 other product NDCs are listed under this name. See all Amlodipine and Olmesartan Medoxomil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amlodipine and Olmesartan Medoxomil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-445 | 31722-0445-3031722-0445-90 |
| Amlodipine and Olmesartan Medoxomilaamlodipine and olmesartan medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-446 | 31722-0446-3031722-0446-90 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-447 | 31722-0447-3031722-0447-90 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-448 | 31722-0448-3031722-0448-90 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-001 | 42291-0001-30 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-002 | 42291-0002-30 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-003 | 42291-0003-30 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-004 | 42291-0004-30 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc | 50228-366 | 50228-0366-1050228-0366-3050228-0366-90 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc | 50228-367 | 50228-0367-1050228-0367-3050228-0367-90 |
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 | AvKARE | 42291-002 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-003 |
| 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 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc | 50228-368 |
| 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 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc | 50228-367 |
| Amlodipine and Olmesartan Medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals NY LLC | 69238-2676 |
| 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 5 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-001 |