NDC codes

FDA NDC Directory
Product NDC (as listed)80725-388Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80725-0388Add 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
80725-388-138072503881330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80725-388-13)Marketed from Nov 7, 2022

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)
Coreg CR
Generic name (nonproprietary)
carvedilol phosphate
Active ingredients
Carvedilol phosphate — 80 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022012
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
Identifiers
Product ID 80725-388_d756f678-86ff-4187-9cc1-68dd3a383af8SPL ID d756f678-86ff-4187-9cc1-68dd3a383af8SPL set ID d3625d78-6eb6-41fe-8f6f-664965c104c4RxCUI 860510, 860512, 860516, 860518, 860522, 860524, 860532, 860534UNII EQT531S367UPC 0380725387137, 0380725388134, 0380725385133, 0380725383139
Pharmacologic class
alpha-Adrenergic Blocker; beta-Adrenergic 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

N480725038813 followed by a unit qualifier and the quantity

Package 80725-0388-13. 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 .

Indications (excerpt from the label)

COREG CR is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure. ( 1.1 ) left ventricular dysfunction following myocardial infarction in clinically stable patients. ( 1.2 ) hypertension. ( 1.3 ) 1.1 Heart Failure COREG CR is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4) , Clinical Studies (14.1) ] . 1.2 Left Ventricular Dysfunction following Myocardial Infarction COREG CR is indicated to reduce cardiovascular mort…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022012

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

FDA NDC Directory listings under NDA 022012
ProductStrengthForm · routeLabelerProduct NDC
Coreg CRcarvedilol phosphateCarvedilol phosphate 10 mg/1Capsule, Extended releaseOralWaylis Therapeutics LLC80725-383
Coreg CRcarvedilol phosphateCarvedilol phosphate 20 mg/1Capsule, Extended releaseOralWaylis Therapeutics LLC80725-385
Coreg CRcarvedilol phosphateCarvedilol phosphate 40 mg/1Capsule, Extended releaseOralWaylis Therapeutics LLC80725-387

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Coreg CR (carvedilol phosphate) NDC 80725-388 | Med-Code