NDC codes

FDA NDC Directory
Product NDC (as listed)61919-365Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61919-0365Add 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
61919-365-216191903652121 TABLET in 1 DOSE PACK (61919-365-21)Marketed from Jan 1, 2014

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
DIRECT RX
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040584
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 61919-365_4d3fa8d2-31a1-759a-e063-6294a90a0267SPL ID 4d3fa8d2-31a1-759a-e063-6294a90a0267SPL set ID 2a053775-6f6a-455e-b9a8-8b60e6062db3RxCUI 312617, 763181UNII 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

N461919036521 followed by a unit qualifier and the quantity

Package 61919-0365-21. 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 & USAGE 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 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 require low-dose maintenance therapy) Ankylosing spondylitis Acu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040584

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

FDA NDC Directory listings under ANDA 040584
ProductStrengthForm · routeLabelerProduct NDC
PrednisonePrednisone 1 mg/1TabletOralPar Health USA, LLC0603-5335
PrednisonePrednisone 1 mg/1TabletOralBryant Ranch Prepack71335-3129
PrednisonePrednisone 1 mg/1TabletOralBryant Ranch Prepack63629-2254
PrednisonePrednisone 1 mg/1TabletOralBryant Ranch Prepack72162-1169

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