Prescription drug · ANDA
olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide NDC 70436-016
Olmesartan medoxomil 40 mg/1 + 2 more ingredients · Tablet, Film coated · Oral · Slate Run Pharmaceuticals, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)70436-016Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70436-0016Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70436-016-04 | 7043600160470436001604 | 30 TABLET, FILM COATED in 1 BOTTLE (70436-016-04)Marketed from May 15, 2025 | |
| 70436-016-06 | 7043600160670436001606 | 90 TABLET, FILM COATED in 1 BOTTLE (70436-016-06)Marketed from May 15, 2025 |
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 and amlodipine besylate and hydrochlorothiazide
- Generic name (nonproprietary)
- olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide
- Active ingredients
- Olmesartan medoxomil — 40 mg/1Amlodipine besylate — 5 mg/1Hydrochlorothiazide — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Slate Run Pharmaceuticals, LLCNDC labeler code 70436
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210718
- 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 70436-016_d306cb9e-4244-49dd-9297-9cb6ca69cae9SPL ID d306cb9e-4244-49dd-9297-9cb6ca69cae9SPL set ID a469adff-25a6-4983-b471-60924d920a86RxCUI 999967, 999986, 999991, 999996, 1000001UNII 0J48LPH2TH, 6M97XTV3HD, 864V2Q084HUPC 0370436018048, 0370436016044, 0370436014040, 0370436015047, 0370436017041
- 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
N470436001604followed by a unit qualifier and the quantityPackage 70436-0016-04. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 70436-016
- What is NDC 70436-016?
- 70436-016 is the product NDC for olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide, Olmesartan medoxomil 40 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Slate Run Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide.
- What is the active ingredient?
- Olmesartan medoxomil, Amlodipine besylate, Hydrochlorothiazide.
- Who is the labeler?
- Slate Run Pharmaceuticals, LLC, NDC labeler code 70436. 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 and amlodipine besylate and hydrochlorothiazide?
- 4 other product NDCs are listed under this name. See all olmesartan medoxomil and amlodipine besylate and 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 and amlodipine besylate and 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 and amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 20 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-014 | 70436-0014-0470436-0014-06 |
| olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-015 | 70436-0015-0470436-0015-06 |
| olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-017 | 70436-0017-0470436-0017-06 |
| olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-018 | 70436-0018-0470436-0018-06 |
Other NDCs under ANDA 210718
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 and amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 20 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-014 |
| olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-015 |
| olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-017 |
| olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide | Olmesartan medoxomil 40 mg/1 + 2 more ingredients | Tablet, Film coatedOral | Slate Run Pharmaceuticals, LLC | 70436-018 |