Prednisone NDC 0378-0641

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-0641Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-0641Add 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
0378-0641-01	00378064101	100 TABLET in 1 BOTTLE, PLASTIC (0378-0641-01)Marketed from Apr 3, 2019
0378-0641-10	00378064110	1000 TABLET in 1 BOTTLE, PLASTIC (0378-0641-10)Marketed from Apr 3, 2019

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
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 088832
Marketing start: Apr 3, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0378-0641_f7cba7fb-7b9f-4464-a702-5c4f818aeb5fSPL ID f7cba7fb-7b9f-4464-a702-5c4f818aeb5fSPL set ID fec09050-5ac2-451b-a2b9-5a21b2def212RxCUI 198145, 312615, 312617UNII VB0R961HZTUPC 0303780641013, 0303780640016, 0303780642010
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

N400378064101 followed by a unit qualifier and the quantity

Package 00378-0641-01. 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 23, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Prednisone tablets 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; hypercalcemia associated with cancer; nonsuppurative thyroiditis. 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 m…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 088832

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

FDA NDC Directory listings under ANDA 088832
Product	Strength	Form · route	Labeler	Product NDC
Prednisone	Prednisone 10 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-922
Prednisone	Prednisone 10 mg/1	TabletOral	Northwind Health Company, LLC	51655-935