Prescription drug · ANDA
Valsartan NDC 55111-733
Valsartan 160 mg/1 · Tablet, Film coated · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-733-01 | 55111073301 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-733-01)Marketed from Oct 5, 2021 | |
| 55111-733-05 | 55111073305 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-733-05)Marketed from Oct 5, 2021 | |
| 55111-733-30 | 55111073330 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-733-30)Marketed from Oct 5, 2021 | |
| 55111-733-60 | 55111073360 | 60 TABLET, FILM COATED in 1 BOTTLE (55111-733-60)Marketed from Oct 5, 2021 | |
| 55111-733-78 | 55111073378 | 10 BLISTER PACK in 1 CARTON (55111-733-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-733-79)Marketed from Oct 5, 2021 | |
| 55111-733-90 | 55111073390 | 90 TABLET, FILM COATED in 1 BOTTLE (55111-733-90)Marketed from Oct 5, 2021 |
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)
- Valsartan
- Generic name (nonproprietary)
- valsartan
- Active ingredients
- Valsartan — 160 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201618
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55111-733_f7d1bd41-da10-005a-6e30-8a816db87867SPL ID f7d1bd41-da10-005a-6e30-8a816db87867SPL set ID 75235313-8a07-8849-9b5a-12887992033eRxCUI 349199, 349200, 349201, 349483UNII 80M03YXJ7I
- Pharmacologic class
- Angiotensin 2 Receptor 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
N455111073301followed by a unit qualifier and the quantityPackage 55111-0733-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Valsartan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) Heart failure (NYHA class II to IV), to reduce hospitalization for heart failure in adults (1.2) Post-myocardial infarction , for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults (1.3) 1.1 Hypertension Valsartan tablets are indicated for the treatment of hypertension, to lower blood pre…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201618
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 |
|---|---|---|---|---|
| Valsartan | Valsartan 40 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-731 |
| Valsartan | Valsartan 80 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-732 |
| Valsartan | Valsartan 320 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-734 |