olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide NDC 49884-788

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 — 5 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

Oct 26, 2016

Listing expires

Dec 31, 2027

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 49884-788_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

N449884078809 followed by a unit qualifier and the quantity Copy

Package 49884-0788-09. 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 49884-788

What is NDC 49884-788?

49884-788 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.

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.