Prescription drug · ANDA
Losartan potassium Tablets, 100 mg NDC 63629-2428
losartan potassium · Losartan potassium 100 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2428-1 | 63629242801 | 1000 TABLET in 1 BOTTLE (63629-2428-1)Marketed from Feb 25, 2021 |
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)
- Losartan potassium Tablets, 100 mg
- Generic name (nonproprietary)
- losartan potassium
- Active ingredients
- Losartan potassium — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201170
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63629-2428_cc3b2478-5ab1-4ee0-a162-a05b3c4f6b09SPL ID cc3b2478-5ab1-4ee0-a162-a05b3c4f6b09SPL set ID 04c4ba11-a9bd-4fed-bf14-14214f33f9c2RxCUI 979480UNII 3ST302B24A
- 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
N463629242801followed by a unit qualifier and the quantityPackage 63629-2428-01. 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)
Losartan potassium is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. ( 1.2 ) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. ( 1.3 ) 1.1 Hypertension Losartan potassium is indicated for…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201170
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 |
|---|---|---|---|---|
| Losartan potassium Tablets, 100 mglosartan potassium | Losartan potassium 100 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1698 |
| Losartan potassium Tablets, 25 mglosartan potassium | Losartan potassium 25 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1696 |
| Losartan potassium Tablets, 50 mglosartan potassium | Losartan potassium 50 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1697 |
| Losartan potassium Tablets, 50 mglosartan potassium | Losartan potassium 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1817 |
| Losartan potassium Tablets, 100 mglosartan potassium | Losartan potassium 100 mg/1 | TabletOral | Coupler LLC | 67046-1511 |
| Losartan potassium Tablets, 50 mglosartan potassium | Losartan potassium 50 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-334 |
| Losartan potassium Tablets, 25 mglosartan potassium | Losartan potassium 25 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-333 |
| Losartan potassium Tablets, 100 mglosartan potassium | Losartan potassium 100 mg/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-335 |
| Losartan potassium Tablets, 50 mglosartan potassium | Losartan potassium 50 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9192 |
| Losartan potassium Tablets, 25 mglosartan potassium | Losartan potassium 25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2426 |