Prescription drug · ANDA

prednisone NDC 0615-8440

Prednisone 10 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs

NDC codes

FDA NDC Directory
Product NDC (as listed)0615-8440Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-8440Add 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
0615-8440-050061584400515 TABLET in 1 BLISTER PACK (0615-8440-05)Marketed from Oct 27, 2022
0615-8440-390061584403930 TABLET in 1 BLISTER PACK (0615-8440-39)Marketed from Oct 27, 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 — 10 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213386
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 0615-8440_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

N400615844005 followed by a unit qualifier and the quantity

Package 00615-8440-05. 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)

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)

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
ProductStrengthForm · routeLabelerProduct NDC
prednisonePrednisone 20 mg/1TabletOralRedpharm Drug67296-2081
prednisonePrednisone 10 mg/1TabletOralA-S Medication Solutions50090-7369
prednisonePrednisone 10 mg/1TabletOralA-S Medication Solutions50090-7371
prednisonePrednisone 20 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8441
prednisonePrednisone 10 mg/1TabletOralUnit Dose Solutions, Inc.87441-069
prednisonePrednisone 20 mg/1TabletOralA-S Medication Solutions50090-6123
prednisonePrednisone 10 mg/1TabletOralAmneal Pharmaceuticals NY LLC60219-1707
prednisonePrednisone 20 mg/1TabletOralA-S Medication Solutions50090-6122
prednisonePrednisone 20 mg/1TabletOralAmneal Pharmaceuticals NY LLC60219-1708
prednisonePrednisone 10 mg/1TabletOralREMEDYREPACK INC.70518-4354
prednisonePrednisone 20 mg/1TabletOralREMEDYREPACK INC.70518-3540
prednisonePrednisone 20 mg/1TabletOralProficient Rx LP71205-797
prednisonePrednisone 20 mg/1TabletOralA-S Medication Solutions50090-6259
prednisonePrednisone 10 mg/1TabletOralProficient Rx LP71205-818

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prednisone NDC 0615-8440 | Med-Code