NDC codes

FDA NDC Directory
Product NDC (as listed)68462-165Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0165Add 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
68462-165-016846201650168462016501100 TABLET, FILM COATED in 1 BOTTLE (68462-165-01)Marketed from Sep 5, 2007
68462-165-056846201650568462016505500 TABLET, FILM COATED in 1 BOTTLE (68462-165-05)Marketed from Sep 5, 2007
68462-165-1068462016510684620165101000 TABLET, FILM COATED in 1 BOTTLE (68462-165-10)Marketed from Sep 5, 2007
68462-165-186846201651868462016518180 TABLET, FILM COATED in 1 BOTTLE (68462-165-18)Marketed from Dec 10, 2014
68462-165-60684620165606846201656060 TABLET, FILM COATED in 1 BOTTLE (68462-165-60)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 — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078251
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
Identifiers
Product ID 68462-165_5f5b2d20-cc2a-4e91-b2b9-260e7438ab2cSPL ID 5f5b2d20-cc2a-4e91-b2b9-260e7438ab2cSPL set ID c4a21f67-7812-4634-beba-f8e85c63c5f2RxCUI 200031, 200032, 200033, 686924UNII 0K47UL67F2UPC 0368462162019, 0368462163016, 0368462164013, 0368462165010
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

N468462016501 followed by a unit qualifier and the quantity

Package 68462-0165-01. 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 .

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-165

What is NDC 68462-165?
68462-165 is the product NDC for Carvedilol, Carvedilol 25 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 5 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?
Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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?
169 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 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

All 170 Carvedilol NDCs

Other NDCs under ANDA 078251

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

FDA NDC Directory listings under ANDA 078251
ProductStrengthForm · routeLabelerProduct NDC
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7305
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7306
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7307
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7308
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2119
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2175
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4898
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6865
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-033
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2640
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2641
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2648
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2649
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralProficient Rx LP63187-131
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralRedpharm Drug67296-2298
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2773
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4816
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-162
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-163
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-164

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