Prescription drug · NDA
Norvasc (Amlodipine besylate) NDC 58151-355
Amlodipine besylate 10 mg/1 · Tablet · Oral · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58151-355-77 | 5815103557758151035577 | 90 TABLET in 1 BOTTLE (58151-355-77)Marketed from May 24, 2024 | |
| 58151-355-88 | 5815103558858151035588 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (58151-355-88) / 1 TABLET in 1 BLISTER PACKMarketed from Feb 9, 2024 |
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)
- Norvasc
- Generic name (nonproprietary)
- amlodipine besylate
- Active ingredients
- Amlodipine besylate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Viatris Specialty LLCNDC labeler code 58151
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019787
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 58151-355_643fa1a0-53d9-4ce8-bc04-44285b006997SPL ID 643fa1a0-53d9-4ce8-bc04-44285b006997SPL set ID 7367289c-b0b0-466a-83e2-558e2985c29fRxCUI 197361, 212542, 212549, 212575, 308135, 308136UNII 864V2Q084HUPC 0358151354771
- 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
N458151035577followed by a unit qualifier and the quantityPackage 58151-0355-77. 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)
NORVASC 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 NORVASC is 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 NORVASC ® is indicated for the treatment of hypertension, to lowe…
Excerpt only. Read the full label for complete information.
About NDC 58151-355
- What is NDC 58151-355?
- 58151-355 is the product NDC for Norvasc (amlodipine besylate), Amlodipine besylate 10 mg/1 tablet, listed with the FDA by Viatris Specialty LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Norvasc (Amlodipine besylate).
- What is the active ingredient?
- Amlodipine besylate.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 58151. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Norvasc?
- 5 other product NDCs are listed under this name. See all Norvasc NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Norvasc products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Norvascamlodipine besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Viatris Specialty LLC | 58151-353 | 58151-0353-77 |
| Norvascamlodipine besylate | Amlodipine besylate 5 mg/1 | TabletOral | Viatris Specialty LLC | 58151-354 | 58151-0354-3058151-0354-7758151-0354-88 |
| Norvascamlodipine besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | PFIZER LABORATORIES DIV PFIZER INC | 0069-1520 | 00069-1520-68 |
| Norvascamlodipine besylate | Amlodipine besylate 5 mg/1 | TabletOral | PFIZER LABORATORIES DIV PFIZER INC | 0069-1530 | 00069-1530-68 |
| Norvascamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | PFIZER LABORATORIES DIV PFIZER INC | 0069-1540 | 00069-1540-68 |
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 |
|---|---|---|---|---|
| amlodipine besylate | Amlodipine besylate 5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-2010 |
| amlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-2135 |
| amlodipine besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-2242 |
| amlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-469 |
| Norvascamlodipine besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | PFIZER LABORATORIES DIV PFIZER INC | 0069-1520 |
| Norvascamlodipine besylate | Amlodipine besylate 5 mg/1 | TabletOral | PFIZER LABORATORIES DIV PFIZER INC | 0069-1530 |
| Norvascamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | PFIZER LABORATORIES DIV PFIZER INC | 0069-1540 |
| Norvascamlodipine besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Viatris Specialty LLC | 58151-353 |
| Norvascamlodipine besylate | Amlodipine besylate 5 mg/1 | TabletOral | Viatris Specialty LLC | 58151-354 |