Prescription drug · ANDA

prednisone NDC 70518-3539

Prednisone 5 mg/1 · Tablet · Oral · REMEDYREPACK INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-3539Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-3539Add 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
70518-3539-1705183539017051835390130 TABLET in 1 BLISTER PACK (70518-3539-1)Marketed from Jan 22, 2025
70518-3539-27051835390270518353902180 TABLET in 1 BOTTLE, PLASTIC (70518-3539-2)Marketed from Feb 6, 2025
70518-3539-3705183539037051835390321 TABLET in 1 BOTTLE, PLASTIC (70518-3539-3)Marketed from Oct 15, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208412
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 70518-3539_5dbb6a3b-d36b-fef4-e063-6294a90a548fSPL ID 5dbb6a3b-d36b-fef4-e063-6294a90a548f
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

N470518353901 followed by a unit qualifier and the quantity

Package 70518-3539-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 70518-3539

What is NDC 70518-3539?
70518-3539 is the product NDC for prednisone, Prednisone 5 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 3 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?
REMEDYREPACK INC., NDC labeler code 70518. 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?
281 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 10 mg/1TabletOralCoupler LLC67046-129467046-1294-03
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

All 282 prednisone NDCs

Other NDCs under ANDA 208412

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

FDA NDC Directory listings under ANDA 208412
ProductStrengthForm · routeLabelerProduct NDC
prednisonePrednisone 10 mg/1TabletOralQPharma Inc42708-166
prednisonePrednisone 5 mg/1TabletOralQPharma Inc42708-186
prednisonePrednisone 20 mg/1TabletOralMedsource Pharmaceuticals45865-884
prednisonePrednisone 5 mg/1TabletOralA-S Medication Solutions50090-5816
prednisonePrednisone 50 mg/1TabletOralA-S Medication Solutions50090-6376
prednisonePrednisone 10 mg/1TabletOralA-S Medication Solutions50090-7218
prednisonePrednisone 10 mg/1TabletOralA-S Medication Solutions50090-7219
prednisonePrednisone 5 mg/1TabletOralA-S Medication Solutions50090-7505
prednisonePrednisone 20 mg/1TabletOralA-S Medication Solutions50090-8051
prednisonePrednisone 20 mg/1TabletOralA-S Medication Solutions50090-8052
prednisonePrednisone 50 mg/1TabletOralNorthwind Health Company, LLC51655-349
prednisonePrednisone 20 mg/1TabletOralNorthwind Health Company, LLC51655-541
prednisonePrednisone 10 mg/1TabletOralNorthwind Health Company, LLC51655-972
PrednisonePrednisone 20 mg/1TabletOralCardinal Health 107, LLC55154-2581
prednisonePrednisone 5 mg/1TabletOralCardinal Health 107, LLC55154-2582
PrednisonePrednisone 50 mg/1TabletOralAmerican Health Packaging60687-854
prednisonePrednisone 5 mg/1TabletOralAmerican Health Packaging60687-903
PrednisonePrednisone 10 mg/1TabletOralAmerican Health Packaging60687-914
PrednisonePrednisone 20 mg/1TabletOralAmerican Health Packaging60687-925
prednisonePrednisone 20 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-790

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