What is NDC 53401-045?

53401-045 is the product NDC for Carvedilol, Carvedilol 6.25 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Carvedilol NDC 53401-045 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53401-045Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53401-0045Add 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 NDC	11-digit (billing)	Package	Copy
53401-045-80	5340100458053401004580	180 TABLET, FILM COATED in 1 BOTTLE (53401-045-80)Marketed from Oct 27, 2026

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: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 53401
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078165
Marketing start: Jul 29, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
Identifiers: Product ID 53401-045_5eed047a-61f2-1b64-e063-6294a90a96eeSPL ID 5eed047a-61f2-1b64-e063-6294a90a96eeSPL set ID 5eed0213-2953-0d68-e063-6394a90a6084UNII 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

N453401004580 followed by a unit qualifier and the quantity

Package 53401-0045-80. 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 Oct 28, 2026.

Indications (excerpt from the label)

Carvedilol 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 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 is indicated to reduce cardiovascular…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53401-045

What is NDC 53401-045?: 53401-045 is the product NDC for Carvedilol, Carvedilol 6.25 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-690	72189-0690-90
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0973	67046-0973-03
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0879	67046-0879-03
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0336	67046-0336-03
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-664	72189-0664-60
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-663	72189-0663-90
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-653	72189-0653-90
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1616	67046-1616-03
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	Advagen Pharma Limited	72888-501	72888-0501-0172888-0501-0272888-0501-03
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Advagen Pharma Limited	72888-499	72888-0499-0172888-0499-0272888-0499-03

All 170 Carvedilol NDCs

Other NDCs under ANDA 078165

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

FDA NDC Directory listings under ANDA 078165
Product	Strength	Form · route	Labeler	Product NDC
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-431
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	RedPharm Drug, Inc	67296-1899
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	RedPharm Drug, Inc	67296-1901
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-440
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2023
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2026
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2033
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8231
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3970
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-5311
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7849
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7850
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	Advagen Pharma Ltd	72888-035
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Advagen Pharma Ltd	72888-034
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	Advagen Pharma Ltd	72888-036
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	Advagen Pharma Ltd	72888-037