NDC codes

FDA NDC Directory
Product NDC (as listed)67046-1616Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67046-1616Add 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
67046-1616-36704616160330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1616-3)Marketed from Nov 21, 2025

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
Labeler
Coupler LLCNDC labeler code 67046
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078384
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
Identifiers
Product ID 67046-1616_441dd9f2-040e-dba0-e063-6394a90a80bcSPL ID 441dd9f2-040e-dba0-e063-6394a90a80bcSPL set ID 441dda59-c3c4-d3c6-e063-6394a90a98dcRxCUI 686924UNII 0K47UL67F2
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

N467046161603 followed by a unit qualifier and the quantity

Package 67046-1616-03. 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 Tablet 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 Carvedilol Tablets 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 Carvedilol Tablet is indicated to red…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-1616

What is NDC 67046-1616?
67046-1616 is the product NDC for Carvedilol, Carvedilol 3.125 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Carvedilol.
What is the active ingredient?
Carvedilol.
Who is the labeler?
Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Carvedilol?
167 other product NDCs are listed under this name. See all Carvedilol 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 Carvedilol NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralCoupler LLC67046-097367046-0973-03
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralCoupler LLC67046-087967046-0879-03
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralCoupler LLC67046-033667046-0336-03
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralDirect_Rx72189-66472189-0664-60
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralDirect_Rx72189-66372189-0663-90
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralDirect_Rx72189-65372189-0653-90
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralAdvagen Pharma Limited72888-50172888-0501-0172888-0501-0272888-0501-03
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralAdvagen Pharma Limited72888-49972888-0499-0172888-0499-0272888-0499-03
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralAdvagen Pharma Limited72888-50072888-0500-0172888-0500-0272888-0500-03
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralAdvagen Pharma Limited72888-50272888-0502-0172888-0502-0272888-0502-03

All 168 Carvedilol NDCs

Other NDCs under ANDA 078384

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

FDA NDC Directory listings under ANDA 078384
ProductStrengthForm · routeLabelerProduct NDC
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2474
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5275
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-713
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralUNICHEM PHARMACEUTICALS (USA), INC.76385-112
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralUNICHEM PHARMACEUTICALS (USA), INC.76385-110
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralUNICHEM PHARMACEUTICALS (USA), INC.76385-111
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralUNICHEM PHARMACEUTICALS (USA), INC.76385-113
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-943
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralProficient Rx LP82804-183
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-040
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-039
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralDirect_Rx72189-653
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-041
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-042
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1407
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1813
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-062
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-067
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-063
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-066

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