Prescription drug · ANDA
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide NDC 49884-790
Olmesartan medoxomil 40 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-790-09 | 49884079009 | 90 TABLET, FILM COATED in 1 BOTTLE (49884-790-09)Marketed from Oct 26, 2016 | |
| 49884-790-11 | 49884079011 | 30 TABLET, FILM COATED in 1 BOTTLE (49884-790-11)Marketed from Oct 26, 2016 |
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)
- olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
- Generic name (nonproprietary)
- olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
- Active ingredients
- Olmesartan medoxomil — 40 mg/1Amlodipine besylate — 10 mg/1Hydrochlorothiazide — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 49884
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206137
- Marketing start
- Listing expires
- Other FDA classes
- Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
- Identifiers
- Product ID 49884-790_6bb29932-f583-4898-a9eb-df490652515eSPL ID 6bb29932-f583-4898-a9eb-df490652515e
- Pharmacologic class
- Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker; Thiazide Diuretic
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
N449884079009followed by a unit qualifier and the quantityPackage 49884-0790-09. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 49884-790
- What is NDC 49884-790?
- 49884-790 is the product NDC for olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide, Olmesartan medoxomil 40 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Par Health USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide.
- What is the active ingredient?
- Olmesartan medoxomil, Amlodipine besylate, Hydrochlorothiazide.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 49884. 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 / amlodipine besylate / hydrochlorothiazide?
- 12 other product NDCs are listed under this name. See all olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide 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 / amlodipine besylate / hydrochlorothiazide 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 / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4165 | 70518-4165-00 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 20 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Par Health USA, LLC | 49884-786 | 49884-0786-0949884-0786-11 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Par Health USA, LLC | 49884-787 | 49884-0787-0949884-0787-11 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Par Health USA, LLC | 49884-788 | 49884-0788-0949884-0788-11 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Par Health USA, LLC | 49884-789 | 49884-0789-0949884-0789-11 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 20 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2238 | 63629-2238-01 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 20 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2239 | 63629-2239-01 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2240 | 63629-2240-01 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2241 | 63629-2241-01 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 20 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1514 | 72162-1514-0372162-1514-09 |
All 13 olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide NDCs
Other NDCs under ANDA 206137
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 / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 20 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Par Health USA, LLC | 49884-786 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Par Health USA, LLC | 49884-787 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Par Health USA, LLC | 49884-788 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Par Health USA, LLC | 49884-789 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 20 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2238 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 20 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2239 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2240 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2241 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4165 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 20 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1514 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1515 |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1516 |