What is NDC 0615-8441?

0615-8441 is the product NDC for prednisone, Prednisone 20 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 3 package NDCs, 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 prednisone?

282 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

prednisone NDC 0615-8441 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8441Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8441Add 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
0615-8441-00	00615844100	5 TABLET in 1 BLISTER PACK (0615-8441-00)Marketed from Jul 5, 2024
0615-8441-10	00615844110	10 TABLET in 1 BLISTER PACK (0615-8441-10)Marketed from Aug 7, 2023
0615-8441-39	00615844139	30 TABLET in 1 BLISTER PACK (0615-8441-39)Marketed from Nov 10, 2022

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): prednisone
Generic name (nonproprietary): prednisone
Active ingredients: Prednisone — 20 mg/1
Dosage form: Tablet
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 213386
Marketing start: Jun 24, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0615-8441_d607202d-61e1-4a93-8456-04833ad570ffSPL ID d607202d-61e1-4a93-8456-04833ad570ffSPL set ID 7b60255f-7d0b-4f91-a75c-6682ac446f6bRxCUI 198145, 312615UNII VB0R961HZT
Pharmacologic class: Corticosteroid

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

N400615844100 followed by a unit qualifier and the quantity

Package 00615-8441-00. 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 Aug 12, 2024.

Indications (excerpt from the label)

INDICATIONS Prednisone tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Hypercalcemia associated with cancer Nonsuppurative thyroiditis 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may requir…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8441

What is NDC 0615-8441?: 0615-8441 is the product NDC for prednisone, Prednisone 20 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: prednisone.
What is the active ingredient?: Prednisone.
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 prednisone?: 282 other product NDCs are listed under this name. See all prednisone 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 prednisone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
PredniSONE	Prednisone 20 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4182	68788-4182-0168788-4182-0268788-4182-03+3 more
prednisone	Prednisone 10 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-069	87441-0069-01
prednisone	Prednisone 50 mg/1	TabletOral	Coupler LLC	67046-1171	67046-1171-03
prednisone	Prednisone 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2582	55154-2582-00
prednisone	Prednisone 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4660	70518-4660-00
Prednisone	Prednisone 50 mg/1	TabletOral	Coupler LLC	67046-1379	67046-1379-03
Prednisone	Prednisone 20 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2581	55154-2581-00
Prednisone	Prednisone 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4560	70518-4560-00
prednisone	Prednisone 5 mg/1	TabletOral	American Health Packaging	60687-903	60687-0903-01
prednisone	Prednisone 5 mg/1	TabletOral	Coupler LLC	67046-1642	67046-1642-03

All 283 prednisone NDCs

Other NDCs under ANDA 213386

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

FDA NDC Directory listings under ANDA 213386
Product	Strength	Form · route	Labeler	Product NDC
prednisone	Prednisone 20 mg/1	TabletOral	A-S Medication Solutions	50090-6122
prednisone	Prednisone 20 mg/1	TabletOral	A-S Medication Solutions	50090-6123
prednisone	Prednisone 20 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	60219-1708
prednisone	Prednisone 10 mg/1	TabletOral	Amneal Pharmaceuticals NY LLC	60219-1707
prednisone	Prednisone 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4354
prednisone	Prednisone 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-3540
prednisone	Prednisone 10 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8440
prednisone	Prednisone 20 mg/1	TabletOral	Proficient Rx LP	71205-797
prednisone	Prednisone 20 mg/1	TabletOral	A-S Medication Solutions	50090-6259
prednisone	Prednisone 10 mg/1	TabletOral	Proficient Rx LP	71205-818
prednisone	Prednisone 20 mg/1	TabletOral	Redpharm Drug	67296-2081
prednisone	Prednisone 10 mg/1	TabletOral	A-S Medication Solutions	50090-7369
prednisone	Prednisone 10 mg/1	TabletOral	A-S Medication Solutions	50090-7371
prednisone	Prednisone 10 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-069