NDC codes

FDA NDC Directory
Product NDC (as listed)70518-4191Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4191Add 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
70518-4191-1705184191017051841910130 TABLET in 1 BOTTLE, PLASTIC (70518-4191-1)Marketed from Sep 30, 2024
70518-4191-3705184191037051841910310 TABLET in 1 BOTTLE, PLASTIC (70518-4191-3)Marketed from Nov 6, 2024
70518-4191-4705184191047051841910418 TABLET in 1 BOTTLE, PLASTIC (70518-4191-4)Marketed from Apr 14, 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 — 10 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 084122
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 70518-4191_5a57b046-29fc-9114-e063-6294a90a6c17SPL ID 5a57b046-29fc-9114-e063-6294a90a6c17SPL set ID 94715919-70bd-46c9-95fc-e151adf39cf9RxCUI 198145UNII 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

N470518419101 followed by a unit qualifier and the quantity

Package 70518-4191-01. 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 .

Indications (excerpt from the label)

INDICATIONS 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 may requir…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-4191

What is NDC 70518-4191?
70518-4191 is the product NDC for PredniSONE, Prednisone 10 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 084122

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

FDA NDC Directory listings under ANDA 084122
ProductStrengthForm · routeLabelerProduct NDC
PredniSONEPrednisone 10 mg/1TabletOralQPharma, Inc.42708-045
PredniSONEPrednisone 10 mg/1TabletOralNorthwind Health Company, LLC51655-493
PredniSONEPrednisone 10 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0485

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