Olmesartan Medoxomil and Hydrochlorothiazide NDC 46708-150

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-150Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0150Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
46708-150-08	46708015008	80 TABLET in 1 CARTON (46708-150-08)Marketed from Apr 24, 2017
46708-150-10	46708015010	100 TABLET in 1 CARTON (46708-150-10)Marketed from Apr 24, 2017
46708-150-30	46708015030	30 TABLET in 1 BOTTLE (46708-150-30)Marketed from Apr 24, 2017
46708-150-90	46708015090	90 TABLET in 1 BOTTLE (46708-150-90)Marketed from Apr 24, 2017
46708-150-91	46708015091	1000 TABLET in 1 BOTTLE (46708-150-91)Marketed from Apr 24, 2017

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 Hydrochlorothiazide
Generic name (nonproprietary): olmesartan medoxomil and hydrochlorothiazide
Active ingredients: Olmesartan medoxomil — 40 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204233
Marketing start: Apr 24, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers: Product ID 46708-150_b993c27f-9ada-45be-bb55-245e11564d83SPL ID b993c27f-9ada-45be-bb55-245e11564d83SPL set ID 8c65d555-8db8-40d9-be30-309ef09f19beRxCUI 403853, 403854, 403855UNII 0J48LPH2TH, 6M97XTV3HDUPC 0346708149307, 0346708151300, 0346708150303
Pharmacologic class: Angiotensin 2 Receptor 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

N446708015008 followed by a unit qualifier and the quantity

Package 46708-0150-08. 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 Jan 19, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension [see Dosage and Administration (2)] . 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 and hydrochlorothiazide …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204233

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204233
Product	Strength	Form · route	Labeler	Product NDC
Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-150
Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-151
Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-151
Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-149
Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-149
Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1	TabletOral	Bryant Ranch Prepack	63629-4307
Olmesartan Medoxomil and Hydrochlorothiazide	Olmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1	TabletOral	REMEDYREPACK INC.	70518-2269