Prescription drug · NDA
Cozaar (Losartan potassium) NDC 78206-122
Losartan potassium 50 mg/1 · Tablet, Film coated · Oral · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-122-01 | 7820601220178206012201 | 30 TABLET, FILM COATED in 1 BOTTLE (78206-122-01)Marketed from Jun 1, 2021 | |
| 78206-122-02 | 7820601220278206012202 | 90 TABLET, FILM COATED in 1 BOTTLE (78206-122-02)Marketed from Jun 1, 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)
- Cozaar
- Generic name (nonproprietary)
- losartan potassium
- Active ingredients
- Losartan potassium — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Organon LLCNDC labeler code 78206
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020386
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 78206-122_998b309b-7dde-4d62-b902-010dd83108feSPL ID 998b309b-7dde-4d62-b902-010dd83108feSPL set ID 9949448f-c3b9-44ee-94ed-c1aca8c90f39RxCUI 979480, 979482, 979485, 979487, 979492, 979494UNII 3ST302B24AUPC 0378206122025, 0378206121011, 0378206123022
- 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
N478206012201followed by a unit qualifier and the quantityPackage 78206-0122-01. 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)
COZAAR 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 COZAAR ® is indicated for the treatment of hype…
Excerpt only. Read the full label for complete information.
About NDC 78206-122
- What is NDC 78206-122?
- 78206-122 is the product NDC for Cozaar (losartan potassium), Losartan potassium 50 mg/1 tablet, film coated, listed with the FDA by Organon LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cozaar (Losartan potassium).
- What is the active ingredient?
- Losartan potassium.
- Who is the labeler?
- Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cozaar?
- 2 other product NDCs are listed under this name. See all Cozaar NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cozaar products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cozaarlosartan potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Organon LLC | 78206-121 | 78206-0121-01 |
| Cozaarlosartan potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Organon LLC | 78206-123 | 78206-0123-0178206-0123-02 |
Other NDCs under NDA 020386
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 |
|---|---|---|---|---|
| Cozaarlosartan potassium | Losartan potassium 25 mg/1 | Tablet, Film coatedOral | Organon LLC | 78206-121 |
| Cozaarlosartan potassium | Losartan potassium 100 mg/1 | Tablet, Film coatedOral | Organon LLC | 78206-123 |