Prescription drug · ANDA

OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE NDC 33342-173

Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)33342-173Labeler and product segments. Claims need a package NDC.
Product NDC at billing width33342-0173Add 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 NDC11-digit (billing)PackageCopy
33342-173-07333420173073334201730730 TABLET, FILM COATED in 1 BOTTLE (33342-173-07)Marketed from Jun 2, 2023
33342-173-10333420173103334201731090 TABLET, FILM COATED in 1 BOTTLE (33342-173-10)Marketed from Jun 2, 2023
33342-173-12333420173123334201731210 BLISTER PACK in 1 CARTON (33342-173-12) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 2, 2023
33342-173-4433342017344333420173441000 TABLET, FILM COATED in 1 BOTTLE (33342-173-44)Marketed from Jun 2, 2023

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

Generic name (nonproprietary)
olmesartan medoxomil and hydrochlorothiazide
Active ingredients
Olmesartan medoxomil — 20 mg/1Hydrochlorothiazide — 12.5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204801
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)Increased Diuresis (Physiologic effect)Thiazides (Chemical structure)
Identifiers
Product ID 33342-173_79da177b-5eeb-4d95-b949-251b7e8c948bSPL ID 79da177b-5eeb-4d95-b949-251b7e8c948bSPL set ID 03ff0f7e-6aa1-4c38-8c9a-5f1c6a56c747RxCUI 403853, 403854, 403855UNII 0J48LPH2TH, 6M97XTV3HDUPC 0333342175076, 0333342173102, 0333342173447, 0333342175441, 0333342174079, 0333342174109, 0333342173072, 0333342175106, 0333342174444
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

N433342017307 followed by a unit qualifier and the quantity

Package 33342-0173-07. 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 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 (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 and hydrochlorothi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-173

What is NDC 33342-173?
33342-173 is the product NDC for OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE, Olmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1 tablet, film coated, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE.
What is the active ingredient?
Olmesartan medoxomil, Hydrochlorothiazide.
Who is the labeler?
Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 HYDROCHLOROTHIAZIDE?
62 other product NDCs are listed under this name. See all OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-478070518-4780-00
Olmesartan medoxomil and hydrochlorothiazideOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-475470518-4754-00
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals Inc50228-34450228-0344-1050228-0344-3050228-0344-90
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals Inc50228-34350228-0343-1050228-0343-3050228-0343-90
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralScieGen Pharmaceuticals Inc50228-34250228-0342-1050228-0342-3050228-0342-90
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-05884677-0058-1084677-0058-90
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-05684677-0056-1084677-0056-90
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.84677-05784677-0057-1084677-0057-90
Olmesartan Medoxomil And HydrochlorothiazideOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-457770518-4577-00
Olmesartan Medoxomil and HydrochlorothiazideOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1TabletOralUmedica Laboratories USA Inc.60290-02560290-0025-0160290-0025-0260290-0025-03+2 more

All 63 OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE NDCs

Other NDCs under ANDA 204801

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

FDA NDC Directory listings under ANDA 204801
ProductStrengthForm · routeLabelerProduct NDC
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7571
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3029
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3030
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3031
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-174
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-175
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4517
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7478
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4780
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 25 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-292
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 20 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-290
OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDEOlmesartan medoxomil 40 mg/1; Hydrochlorothiazide 12.5 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-291

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in