Prescription drug · ANDA
Losartan Potassium NDC 0904-7049
Losartan potassium 100 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7049-61 | 0090470496100904704961 | 100 BLISTER PACK in 1 CARTON (0904-7049-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 4, 2010 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Losartan Potassium
- Generic name (nonproprietary)
- losartan potassium
- Active ingredients
- Losartan potassium — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078243
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0904-7049_f6a19146-6918-4c46-99a9-f8d947e20231SPL ID f6a19146-6918-4c46-99a9-f8d947e20231SPL set ID c15387df-87a4-4784-acb5-7dd550498f8fRxCUI 979480, 979485, 979492UNII 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
N400904704961followed by a unit qualifier and the quantityPackage 00904-7049-61. 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 tablets are 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 t…
Excerpt only. Read the full label for complete information.
About NDC 0904-7049
- What is NDC 0904-7049?
- 0904-7049 is the product NDC for Losartan Potassium, Losartan potassium 100 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Losartan Potassium.
- What is the active ingredient?
- Losartan potassium.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Losartan Potassium?
- 173 other product NDCs are listed under this name. See all Losartan Potassium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Losartan Potassium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Losartan potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-876 | 60760-0876-30 |
| Losartan potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4773 | 70518-4773-00 |
| Losartan Potassiumlosartan | Losartan potassium 50 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4160 | 68788-4160-0368788-4160-09 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4695 | 70518-4695-0070518-4695-01 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-052 | 87441-0052-01 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-053 | 87441-0053-01 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0702 | 67046-0702-03 |
| Losartan potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4127 | 68788-4127-0368788-4127-09 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1088 | 67046-1088-03 |
| Losartan potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4091 | 68788-4091-0368788-4091-09 |
Other NDCs under ANDA 078243
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 | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-4783 |
| Losortan Potassiumlosartan potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-071 |
| Losortan Potassiumlosartan potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-072 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2089 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7958 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-135 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-136 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-137 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7959 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2326 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2327 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2333 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-6643 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7960 |
| Losortan Potassiumlosartan potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1644 |
| Losartan Potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-731 |
| Losartan Potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-729 |
| Losartan Potassium | Losartan potassium 50 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-730 |
| Losortan Potassiumlosartan potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-506 |
| Losortan Potassiumlosartan potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-504 |
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