NDC codes

FDA NDC Directory
Product NDC (as listed)58657-751Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58657-0751Add 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
58657-751-015865707510158657075101100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58657-751-01)Marketed from Dec 3, 2024
58657-751-505865707515058657075150500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58657-751-50)Marketed from Dec 3, 2024

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 — 6.25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Method Pharmaceuticals, LLCNDC labeler code 58657
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078786
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
Identifiers
Product ID 58657-751_41b3fac8-087e-fa78-e063-6294a90a75e1SPL ID 41b3fac8-087e-fa78-e063-6294a90a75e1SPL set ID a6ab5da0-8f22-491d-b007-85d9d4901828RxCUI 200031, 200032, 200033, 686924UNII 0K47UL67F2UPC 0358657753016, 0358657751012, 0358657752019, 0358657750015
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

N458657075101 followed by a unit qualifier and the quantity

Package 58657-0751-01. 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, USP 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, USP 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, USP are in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58657-751

What is NDC 58657-751?
58657-751 is the product NDC for Carvedilol, Carvedilol 6.25 mg/1 tablet, film coated, listed with the FDA by Method Pharmaceuticals, LLC. It has 2 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?
Method Pharmaceuticals, LLC, NDC labeler code 58657. 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 078786

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

FDA NDC Directory listings under ANDA 078786
ProductStrengthForm · routeLabelerProduct NDC
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralMethod Pharmaceuticals, LLC58657-750
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralMethod Pharmaceuticals, LLC58657-752
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralMethod Pharmaceuticals, LLC58657-753
CarvedilolCarvedilol 3.125 mg/1Tablet, Film coatedOralAdvagen Pharma Limited72888-499
CarvedilolCarvedilol 6.25 mg/1Tablet, Film coatedOralAdvagen Pharma Limited72888-500
CarvedilolCarvedilol 12.5 mg/1Tablet, Film coatedOralAdvagen Pharma Limited72888-501
CarvedilolCarvedilol 25 mg/1Tablet, Film coatedOralAdvagen Pharma Limited72888-502

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