Prescription drug · ANDA
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide NDC 63629-2240
Olmesartan medoxomil 40 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2240-1 | 63629224001 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-2240-1)Marketed from Oct 26, 2016 |
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 / amlodipine besylate / hydrochlorothiazide
- Generic name (nonproprietary)
- olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
- Active ingredients
- Olmesartan medoxomil — 40 mg/1Amlodipine besylate — 10 mg/1Hydrochlorothiazide — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- 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 63629-2240_9bab7c1c-a2cb-4234-a1a4-6f6eb28cd23dSPL ID 9bab7c1c-a2cb-4234-a1a4-6f6eb28cd23dSPL set ID 900024f4-23d6-4505-81db-4f643e12858cRxCUI 999986UNII 6M97XTV3HD, 864V2Q084H, 0J48LPH2TH
- 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
N463629224001followed by a unit qualifier and the quantityPackage 63629-2240-01. 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, amlodipine and hydrochlorothiazide tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) 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, amlodipine and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive car…
Excerpt only. Read the full label for complete information.
About NDC 63629-2240
- What is NDC 63629-2240?
- 63629-2240 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 Bryant Ranch Prepack. It has 1 package NDC, 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Par Health USA, LLC | 49884-790 | 49884-0790-0949884-0790-11 |
| 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 | 63629-2241 | 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 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Par Health USA, LLC | 49884-790 |
| 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 | 63629-2241 |
| 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 |