Prescription drug · NDA AUTHORIZED GENERIC
amlodipine besylate NDC 59762-2135
Amlodipine besylate 10 mg/1 · Tablet · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-2135-1 | 59762213501 | 1000 TABLET in 1 BOTTLE (59762-2135-1)Marketed from Nov 13, 2019 | |
| 59762-2135-9 | 59762213509 | 90 TABLET in 1 BOTTLE (59762-2135-9)Marketed from Jun 24, 2019 |
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 besylate
- Generic name (nonproprietary)
- amlodipine besylate
- Active ingredients
- Amlodipine besylate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 019787
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 59762-2135_4826ff96-be7a-460d-8ec0-d6bd025d1162SPL ID 4826ff96-be7a-460d-8ec0-d6bd025d1162SPL set ID 180ee374-24f2-4b9c-9d54-8815f2b1dc9bRxCUI 197361, 308135, 308136UNII 864V2Q084HUPC 0359762201096, 0359762224293
- Pharmacologic class
- 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
N459762213501followed by a unit qualifier and the quantityPackage 59762-2135-01. 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)
Amlodipine besylate is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: • Hypertension ( 1.1 ) o Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. • Coronary Artery Disease ( 1.2 ) o Chronic Stable Angina o Vasospastic Angina (Prinzmetal’s or Variant Angina) o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension Amlodipine besylate tablets are …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 019787
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 |
|---|---|---|---|---|
| Norvascamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | PFIZER LABORATORIES DIV PFIZER INC | 0069-1540 |
| Norvascamlodipine besylate | Amlodipine besylate 5 mg/1 | TabletOral | PFIZER LABORATORIES DIV PFIZER INC | 0069-1530 |
| amlodipine besylate | Amlodipine besylate 5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-2010 |
| amlodipine besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-2242 |
| Norvascamlodipine besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | PFIZER LABORATORIES DIV PFIZER INC | 0069-1520 |
| Norvascamlodipine besylate | Amlodipine besylate 5 mg/1 | TabletOral | Viatris Specialty LLC | 58151-354 |
| amlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-469 |
| Norvascamlodipine besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Viatris Specialty LLC | 58151-353 |
| Norvascamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | Viatris Specialty LLC | 58151-355 |