What is NDC 0615-8388?

0615-8388 is the product NDC for Carvedilol, Carvedilol 6.25 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Carvedilol NDC 0615-8388 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8388Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8388Add 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
0615-8388-39	00615838839	30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8388-39)Marketed from Feb 16, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076373
Marketing start: Sep 6, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
Identifiers: Product ID 0615-8388_d801a448-2fce-468f-8377-1271eeebba96SPL ID d801a448-2fce-468f-8377-1271eeebba96SPL set ID 2fb46fe1-9b7b-4718-9327-2471af22f0b7RxCUI 200031, 200032, 200033, 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

N400615838839 followed by a unit qualifier and the quantity

Package 00615-8388-39. 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 Jun 11, 2025.

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 indicat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8388

What is NDC 0615-8388?: 0615-8388 is the product NDC for Carvedilol, Carvedilol 6.25 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. 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?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
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 6.25 mg/1	Tablet, Film coatedOral	Advagen Pharma Limited	72888-500	72888-0500-0172888-0500-0272888-0500-03
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Advagen Pharma Limited	72888-499	72888-0499-0172888-0499-0272888-0499-03
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	Advagen Pharma Limited	72888-501	72888-0501-0172888-0501-0272888-0501-03

All 168 Carvedilol NDCs

Other NDCs under ANDA 076373

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

FDA NDC Directory listings under ANDA 076373
Product	Strength	Form · route	Labeler	Product NDC
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-7295
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-7296
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	QPharma, Inc.	42708-072
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-0051
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-138
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-0135
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7890
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-191
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-225
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8387
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-270
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8389
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8390