prednisone NDC 0615-8438

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8438Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8438Add 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
0615-8438-39	00615843839	30 TABLET in 1 BLISTER PACK (0615-8438-39)Marketed from Nov 1, 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 — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210785
Marketing start: Sep 1, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0615-8438_747ce29b-7a16-4275-9462-105f49545e89SPL ID 747ce29b-7a16-4275-9462-105f49545e89SPL set ID 202f6840-f3bd-4bed-ab5d-b36d3c4cdf0fRxCUI 198144UNII 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

N400615843839 followed by a unit qualifier and the quantity

Package 00615-8438-39. 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 Nov 10, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Prednisone tablets USP are indicated in the following conditions: 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, nonsuppurative thyroiditis, hypercalcemia associated with cancer. 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210785

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

FDA NDC Directory listings under ANDA 210785
Product	Strength	Form · route	Labeler	Product NDC
prednisone	Prednisone 1 mg/1	TabletOral	Strides Pharma Science Limited	64380-782