NDC codes

FDA NDC Directory
Product NDC (as listed)65841-616Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65841-0616Add 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
65841-616-016584106160165841061601100 TABLET, FILM COATED in 1 BOTTLE (65841-616-01)Marketed from Sep 5, 2007
65841-616-056584106160565841061605500 TABLET, FILM COATED in 1 BOTTLE (65841-616-05)Marketed from Sep 5, 2007
65841-616-17658410616176584106161728 TABLET, FILM COATED in 1 BOTTLE (65841-616-17)Marketed from Sep 5, 2007

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)
Carvedilol
Generic name (nonproprietary)
carvedilol
Active ingredients
Carvedilol — 3.125 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Zydus Lifesciences LimitedNDC labeler code 65841
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 65841-616_98f78a02-849a-4540-85f8-f0ea1eb1f8f1SPL ID 98f78a02-849a-4540-85f8-f0ea1eb1f8f1SPL set ID 29082d8c-bbde-4620-924f-02dcf1764919RxCUI 200031, 200032, 200033, 686924UNII 0K47UL67F2UPC 0368382092014, 0368382093011, 0368382094018
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

N465841061601 followed by a unit qualifier and the quantity

Package 65841-0616-01. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 65841-616

What is NDC 65841-616?
65841-616 is the product NDC for Carvedilol, Carvedilol 3.125 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 3 package NDCs, 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?
Zydus Lifesciences Limited, NDC labeler code 65841. 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 12.5 mg/1Tablet, Film coatedOralDirect_Rx72189-69072189-0690-90
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 3.125 mg/1Tablet, Film coatedOralCoupler LLC67046-161667046-1616-03
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

All 168 Carvedilol NDCs

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 12.5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6878
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2101
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2389
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7786
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8252
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralDirect_Rx72189-663
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-128
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-125
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5726
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralDirect_Rx72189-664
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-126
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-7539
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-127
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-537
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-151
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1377
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-154
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-152
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-153
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6949

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