Prescription drug · ANDA

Prednisone NDC 0603-5338

Prednisone 10 mg/1 · Tablet · Oral · Par Health USA, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)0603-5338Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00603-5338Add 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
0603-5338-150060353381521 TABLET in 1 BOX, UNIT-DOSE (0603-5338-15)Marketed from Jul 12, 2002
0603-5338-2100603533821100 TABLET in 1 BOTTLE, PLASTIC (0603-5338-21)Marketed from Jul 12, 2002
0603-5338-2800603533828500 TABLET in 1 BOTTLE, PLASTIC (0603-5338-28)Marketed from Jul 12, 2002
0603-5338-310060353383148 TABLET in 1 BOX, UNIT-DOSE (0603-5338-31)Marketed from Jul 12, 2002
0603-5338-32006035338321000 TABLET in 1 BOTTLE, PLASTIC (0603-5338-32)Marketed from Jul 12, 2002

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
Par Health USA, LLCNDC labeler code 0603
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040256
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 0603-5338_68bdeba1-553d-4d18-ae66-5eb8a0a880b8SPL ID 68bdeba1-553d-4d18-ae66-5eb8a0a880b8SPL set ID 10fe5a3b-84dc-4600-87c2-b80c97ce18cfRxCUI 198144, 198145, 198146, 312615, 312617, 763179, 763181, 763183, 763185UNII VB0R961HZTUPC 0306035338317, 0306035337211, 0306035338157, 0306035335217, 0306035336214, 0306035337310, 0306035338218
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

N400603533815 followed by a unit qualifier and the quantity

Package 00603-5338-15. 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 AND USAGE 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0603-5338

What is NDC 0603-5338?
0603-5338 is the product NDC for Prednisone, Prednisone 10 mg/1 tablet, listed with the FDA by Par Health USA, LLC. It has 5 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?
Par Health USA, LLC, NDC labeler code 0603. 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?
280 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PredniSONEPrednisone 20 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-418268788-4182-0168788-4182-0268788-4182-03+3 more
prednisonePrednisone 10 mg/1TabletOralUnit Dose Solutions, Inc.87441-06987441-0069-01
prednisonePrednisone 50 mg/1TabletOralCoupler LLC67046-117167046-1171-03
prednisonePrednisone 5 mg/1TabletOralCardinal Health 107, LLC55154-258255154-2582-00
prednisonePrednisone 10 mg/1TabletOralREMEDYREPACK INC.70518-466070518-4660-00
PrednisonePrednisone 50 mg/1TabletOralCoupler LLC67046-137967046-1379-03
PrednisonePrednisone 20 mg/1TabletOralCardinal Health 107, LLC55154-258155154-2581-00
PrednisonePrednisone 10 mg/1TabletOralREMEDYREPACK INC.70518-456070518-4560-00
prednisonePrednisone 5 mg/1TabletOralAmerican Health Packaging60687-90360687-0903-01
prednisonePrednisone 5 mg/1TabletOralCoupler LLC67046-164267046-1642-03

All 281 Prednisone NDCs

Other NDCs under ANDA 040256

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

FDA NDC Directory listings under ANDA 040256
ProductStrengthForm · routeLabelerProduct NDC
PrednisonePrednisone 5 mg/1TabletOralPar Health USA, LLC0603-5337
PrednisonePrednisone 10 mg/1TabletOralMajor Pharmaceuticals0904-6923
PrednisonePrednisone 5 mg/1TabletOralA-S Medication Solutions50090-0439
PrednisonePrednisone 10 mg/1TabletOralA-S Medication Solutions50090-1001
PrednisonePrednisone 10 mg/1TabletOralA-S Medication Solutions50090-1002
PrednisonePrednisone 10 mg/1TabletOralA-S Medication Solutions50090-7023
PrednisonePrednisone 10 mg/1TabletOralA-S Medication Solutions50090-7024
PrednisonePrednisone 10 mg/1TabletOralA-S Medication Solutions50090-7025
PrednisonePrednisone 5 mg/1TabletOralCardinal Health 107, LLC55154-2146
PrednisonePrednisone 10 mg/1TabletOralCardinal Health 107, LLC55154-3564
PrednisonePrednisone 5 mg/1TabletOralAmerican Health Packaging60687-122
PrednisonePrednisone 10 mg/1TabletOralProficient Rx LP63187-037
PrednisonePrednisone 5 mg/1TabletOralProficient Rx LP63187-066
PrednisonePrednisone 5 mg/1TabletOralBryant Ranch Prepack63629-1605
PrednisonePrednisone 10 mg/1TabletOralBryant Ranch Prepack63629-2257
PrednisonePrednisone 5 mg/1TabletOralBryant Ranch Prepack63629-2264
PrednisonePrednisone 5 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC67544-399
PrednisonePrednisone 5 mg/1TabletOralPreferred Pharmaceuticals, Inc.68788-9551
PrednisonePrednisone 5 mg/1TabletOralREMEDYREPACK INC.70518-0305

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