Prescription drug · ANDA
Olmesartan medoxomil NDC 71335-3162
Olmesartan medoxomil 5 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-3162-1 | 71335316201 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-3162-1)Marketed from Jul 27, 2026 | |
| 71335-3162-2 | 71335316202 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-3162-2)Marketed from Jul 27, 2026 |
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)
- Olmesartan medoxomil
- Generic name (nonproprietary)
- olmesartan medoxomil
- Active ingredients
- Olmesartan medoxomil — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217399
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71335-3162_1b9ea11a-c9e8-448d-b999-ac81a1b11a5cSPL ID 1b9ea11a-c9e8-448d-b999-ac81a1b11a5cSPL set ID 6b8585a2-22e0-4a4f-a1c3-24bcdec01834RxCUI 349373UNII 6M97XTV3HD
- 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
N471335316201followed by a unit qualifier and the quantityPackage 71335-3162-01. 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)
Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes …
Excerpt only. Read the full label for complete information.
About NDC 71335-3162
- What is NDC 71335-3162?
- 71335-3162 is the product NDC for Olmesartan medoxomil, Olmesartan medoxomil 5 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Olmesartan medoxomil.
- What is the active ingredient?
- Olmesartan medoxomil.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Olmesartan medoxomil?
- 119 other product NDCs are listed under this name. See all Olmesartan medoxomil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Olmesartan medoxomil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Olmesartan medoxomil | Olmesartan medoxomil 5 mg/1 | TabletOral | NorthStar RxLLC | 72603-950 | 72603-0950-0172603-0950-02 |
| Olmesartan medoxomil | Olmesartan medoxomil 20 mg/1 | TabletOral | NorthStar RxLLC | 72603-951 | 72603-0951-0172603-0951-02 |
| Olmesartan medoxomil | Olmesartan medoxomil 40 mg/1 | TabletOral | NorthStar RxLLC | 72603-952 | 72603-0952-0172603-0952-02 |
| Olmesartan Medoxomil | Olmesartan medoxomil 5 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0848 | 72303-0848-0172303-0848-02 |
| Olmesartan Medoxomil | Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0849 | 72303-0849-0172303-0849-02 |
| Olmesartan Medoxomil | Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0850 | 72303-0850-0172303-0850-02 |
| Olmesartan medoxomil | Olmesartan medoxomil 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4598 | 70518-4598-00 |
| Olmesartan Medoxomil | Olmesartan medoxomil 5 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-009 | 60290-0009-0160290-0009-0260290-0009-03 |
| Olmesartan Medoxomil | Olmesartan medoxomil 20 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-010 | 60290-0010-0160290-0010-0260290-0010-03 |
| Olmesartan Medoxomil | Olmesartan medoxomil 40 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-011 | 60290-0011-0160290-0011-0260290-0011-03 |
Other NDCs under ANDA 217399
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 |
|---|---|---|---|---|
| Olmesartan medoxomil | Olmesartan medoxomil 5 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-165 |
| Olmesartan medoxomil | Olmesartan medoxomil 20 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-166 |
| Olmesartan medoxomil | Olmesartan medoxomil 40 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-167 |