Prescription drug · ANDA
Amlodipine and Valsartan NDC 46708-459
Amlodipine besylate 10 mg/1; Valsartan 160 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-459-10 | 4670804591046708045910 | 100 TABLET, FILM COATED in 1 CARTON (46708-459-10)Marketed from Dec 1, 2016 | |
| 46708-459-30 | 4670804593046708045930 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-459-30)Marketed from Dec 1, 2016 | |
| 46708-459-31 | 4670804593146708045931 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-459-31)Marketed from Dec 1, 2016 | |
| 46708-459-71 | 4670804597146708045971 | 500 TABLET, FILM COATED in 1 BOTTLE (46708-459-71)Marketed from Dec 1, 2016 | |
| 46708-459-90 | 4670804599046708045990 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-459-90)Marketed from Dec 1, 2016 |
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 Valsartan
- Generic name (nonproprietary)
- amlodipine and valsartan
- Active ingredients
- Amlodipine besylate — 10 mg/1Valsartan — 160 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202713
- 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 46708-459_3fb35d37-f05c-44ff-be96-076adaa6da32SPL ID 3fb35d37-f05c-44ff-be96-076adaa6da32SPL set ID a9c442dc-749e-4de0-bca3-1044eb78da72RxCUI 722126, 722131, 722134, 722137UNII 80M03YXJ7I, 864V2Q084HUPC 0346708460303, 0346708461300, 0346708459307, 0346708458300
- 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
N446708045910followed by a unit qualifier and the quantityPackage 46708-0459-10. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Amlodipine and valsartan tablets, USP are the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets, USP are indicated for the treatment of hypertension, to lower blood pressure: In patients not adequately controlled on monotherapy (1) As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1) Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Hypertension Amlodipine and valsartan tablets, USP are indicated for the treatment of hypertension, to…
Excerpt only. Read the full label for complete information.
About NDC 46708-459
- What is NDC 46708-459?
- 46708-459 is the product NDC for Amlodipine and Valsartan, Amlodipine besylate 10 mg/1; Valsartan 160 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amlodipine and Valsartan.
- What is the active ingredient?
- Amlodipine besylate, Valsartan.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 Valsartan?
- 35 other product NDCs are listed under this name. See all Amlodipine and Valsartan 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 Valsartan 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 valsartan | Amlodipine besylate 5 mg/1; Valsartan 160 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-279 | 33342-0279-0733342-0279-1033342-0279-12 |
| amlodipine and valsartan | Amlodipine besylate 10 mg/1; Valsartan 160 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-280 | 33342-0280-0733342-0280-1033342-0280-12 |
| amlodipine and valsartan | Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-281 | 33342-0281-0733342-0281-1033342-0281-12 |
| amlodipine and valsartan | Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-282 | 33342-0282-0733342-0282-1033342-0282-12 |
| Amlodipine and Valsartan | Amlodipine 5 mg/1; Valsartan 160 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-844 | 23155-0844-0323155-0844-09 |
| Amlodipine and Valsartan | Amlodipine 10 mg/1; Valsartan 160 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-845 | 23155-0845-0323155-0845-09 |
| Amlodipine and Valsartan | Amlodipine 5 mg/1; Valsartan 320 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-846 | 23155-0846-0323155-0846-09 |
| Amlodipine and Valsartan | Amlodipine 10 mg/1; Valsartan 320 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-847 | 23155-0847-0323155-0847-09 |
| Amlodipine and Valsartan | Amlodipine besylate 5 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-458 | 46708-0458-1046708-0458-3046708-0458-31+2 more |
| Amlodipine and Valsartan | Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-460 | 46708-0460-1046708-0460-3046708-0460-31+2 more |
Other NDCs under ANDA 202713
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 Valsartan | Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-461 |
| Amlodipine and Valsartan | Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-460 |
| Amlodipine and Valsartan | Amlodipine besylate 5 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-458 |
| Amlodipine and Valsartan | Amlodipine besylate 5 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-205 |
| Amlodipine and Valsartan | Amlodipine besylate 10 mg/1; Valsartan 160 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-206 |
| Amlodipine and Valsartan | Amlodipine besylate 5 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-207 |
| Amlodipine and Valsartan | Amlodipine besylate 10 mg/1; Valsartan 320 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-208 |