Prescription drug · ANDA

Carvedilol NDC 68071-3138

Carvedilol 3.125 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68071-3138Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-3138Add 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
68071-3138-36807131380330 TABLET, FILM COATED in 1 BOTTLE (68071-3138-3)Marketed from Mar 1, 2017
68071-3138-66807131380660 TABLET, FILM COATED in 1 BOTTLE (68071-3138-6)Marketed from Mar 1, 2017
68071-3138-868071313808180 TABLET, FILM COATED in 1 BOTTLE (68071-3138-8)Marketed from Mar 1, 2017
68071-3138-96807131380990 TABLET, FILM COATED in 1 BOTTLE (68071-3138-9)Marketed from Mar 1, 2017

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Carvedilol
Generic name (nonproprietary)
carvedilol
Active ingredients
Carvedilol — 3.125 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077614
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
Identifiers
Product ID 68071-3138_0ec45c14-def9-b2b9-e063-6294a90a3a3aSPL ID 0ec45c14-def9-b2b9-e063-6294a90a3a3aSPL set ID 49afdf89-0bed-71da-e054-00144ff88e88RxCUI 686924UNII 0K47UL67F2UPC 0368071313888
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

N468071313803 followed by a unit qualifier and the quantity

Package 68071-3138-03. 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)

Carvedilol tablets are 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 Carvedilol tablets are 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 ) and Clinical Studies (14.1) ]. 1.2 Left Ventricular Dysfunction following Myocardial Infarction Carvedilol tablets are indicate…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077614

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

FDA NDC Directory listings under ANDA 077614
ProductStrengthForm · routeLabelerProduct NDC
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0426
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralQPharma Inc42708-181
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralDirect_Rx72189-664
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralDirect_Rx72189-663
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-537
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-030
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-029
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-034
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-4060
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6742
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralCoupler LLC67046-0336
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2101
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-4070
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0840
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2230
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-126
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-125
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-127
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-128
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-151

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