Prescription drug · ANDA
Amlodipine besylate and Olmesartran medoxomil NDC 62332-212
Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-212-30 | 62332021230 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-212-30)Marketed from Jul 18, 2017 | |
| 62332-212-90 | 62332021290 | 90 TABLET, FILM COATED in 1 BOTTLE (62332-212-90)Marketed from Jul 18, 2017 | |
| 62332-212-91 | 62332021291 | 1000 TABLET, FILM COATED in 1 BOTTLE (62332-212-91)Marketed from Jul 18, 2017 |
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 besylate and Olmesartran medoxomil
- Generic name (nonproprietary)
- amlodipine besylate and olmesartran medoxomil
- Active ingredients
- Amlodipine besylate — 5 mg/1Olmesartan medoxomil — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.NDC labeler code 62332
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207073
- 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 62332-212_fe578906-d9fc-4f00-9de4-8e02292ad1c0SPL ID fe578906-d9fc-4f00-9de4-8e02292ad1c0SPL set ID 1eb78d80-701d-4766-98c3-feee6790de1aRxCUI 730861, 730866, 730869, 730872UNII 6M97XTV3HD, 864V2Q084HUPC 0362332213306, 0362332215300, 0362332212309, 0362332214303
- 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
N462332021230followed by a unit qualifier and the quantityPackage 62332-0212-30. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Amlodipine and olmesartan medoxomil tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as…
Excerpt only. Read the full label for complete information.
About NDC 62332-212
- What is NDC 62332-212?
- 62332-212 is the product NDC for Amlodipine besylate and Olmesartran medoxomil, Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amlodipine besylate and Olmesartran medoxomil.
- What is the active ingredient?
- Amlodipine besylate, Olmesartan medoxomil.
- Who is the labeler?
- Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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 besylate and Olmesartran medoxomil?
- 7 other product NDCs are listed under this name. See all Amlodipine besylate and Olmesartran 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 besylate and Olmesartran 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 besylate and Olmesartran medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-212 | 46708-0212-3046708-0212-9046708-0212-91 |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-213 | 46708-0213-3046708-0213-9046708-0213-91 |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-214 | 46708-0214-3046708-0214-9046708-0214-91 |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-215 | 46708-0215-3046708-0215-9046708-0215-91 |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-213 | 62332-0213-3062332-0213-9062332-0213-91 |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-214 | 62332-0214-3062332-0214-9062332-0214-91 |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-215 | 62332-0215-3062332-0215-9062332-0215-91 |
Other NDCs under ANDA 207073
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 besylate and Olmesartran medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-212 |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-213 |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-214 |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-215 |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-213 |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-214 |
| Amlodipine besylate and Olmesartran medoxomil | Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-215 |