NDC codes

FDA NDC Directory
Product NDC (as listed)0713-0873Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00713-0873Add 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
0713-0873-30007130873300071308733030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0873-30)Marketed from Sep 1, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Azor
Generic name (nonproprietary)
amlodipine besylate and olmesartan medoxomil
Active ingredients
Amlodipine besylate — 10 mg/1Olmesartan medoxomil — 40 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Cosette Pharmaceuticals, Inc.NDC labeler code 0713
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022100
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers
Product ID 0713-0873_00491aef-cf0c-eeb3-e063-6394a90a716dSPL ID 00491aef-cf0c-eeb3-e063-6394a90a716dSPL set ID c5535406-b63b-49aa-88b9-169aaf0ed08eRxCUI 730861, 730866, 730869, 730872, 744624, 744628, 744632, 744636UNII 6M97XTV3HD, 864V2Q084HUPC 0307130871303, 0307130873307, 0307130872300, 0307130870306
Pharmacologic class
Angiotensin 2 Receptor Blocker; Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker

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

N400713087330 followed by a unit qualifier and the quantity

Package 00713-0873-30. 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)

Azor is 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 Azor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoki…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0713-0873

What is NDC 0713-0873?
0713-0873 is the product NDC for Azor, Amlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1 tablet, film coated, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Azor (Amlodipine besylate and olmesartan medoxomil).
What is the active ingredient?
Amlodipine besylate, Olmesartan medoxomil.
Who is the labeler?
Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Azor?
3 other product NDCs are listed under this name. See all Azor 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 Azor NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Azoramlodipine besylate and olmesartan medoxomilAmlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1Tablet, Film coatedOralCosette Pharmaceuticals, Inc.0713-087000713-0870-30
Azoramlodipine besylate and olmesartan medoxomilAmlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1Tablet, Film coatedOralCosette Pharmaceuticals, Inc.0713-087100713-0871-30
Azoramlodipine besylate and olmesartan medoxomilAmlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1Tablet, Film coatedOralCosette Pharmaceuticals, Inc.0713-087200713-0872-30

Other NDCs under NDA 022100

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

FDA NDC Directory listings under NDA 022100
ProductStrengthForm · routeLabelerProduct NDC
amlodipine besylate and olmesartan medoxomilAmlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-857
amlodipine besylate and olmesartan medoxomilAmlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-858
amlodipine besylate and olmesartan medoxomilAmlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-859
amlodipine besylate and olmesartan medoxomilAmlodipine besylate 10 mg/1; Olmesartan medoxomil 40 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-860
Azoramlodipine besylate and olmesartan medoxomilAmlodipine besylate 5 mg/1; Olmesartan medoxomil 20 mg/1Tablet, Film coatedOralCosette Pharmaceuticals, Inc.0713-0870
Azoramlodipine besylate and olmesartan medoxomilAmlodipine besylate 10 mg/1; Olmesartan medoxomil 20 mg/1Tablet, Film coatedOralCosette Pharmaceuticals, Inc.0713-0871
Azoramlodipine besylate and olmesartan medoxomilAmlodipine besylate 5 mg/1; Olmesartan medoxomil 40 mg/1Tablet, Film coatedOralCosette Pharmaceuticals, Inc.0713-0872

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