NDC codes

FDA NDC Directory
Product NDC (as listed)70954-058Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70954-0058Add 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
70954-058-107095400581070954005810100 TABLET in 1 BOTTLE (70954-058-10)Marketed from Nov 15, 2019
70954-058-2070954005820709540058201000 TABLET in 1 BOTTLE (70954-058-20)Marketed from Nov 15, 2019
70954-058-3070954005830709540058301 BLISTER PACK in 1 BOX (70954-058-30) / 21 TABLET in 1 BLISTER PACKMarketed from May 28, 2020
70954-058-4070954005840709540058401 BLISTER PACK in 1 BOX (70954-058-40) / 48 TABLET in 1 BLISTER PACKMarketed from May 28, 2020

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
ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211575
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 70954-058_f662b658-7133-468c-b35a-ed6083cbff91SPL ID f662b658-7133-468c-b35a-ed6083cbff91SPL set ID f05eb734-07e7-491c-b2e9-aae340e03750RxCUI 198145, 198146, 198148, 312615, 312617, 763179, 763181, 763183, 763185UNII VB0R961HZTUPC 0370954061106, 0370954057109
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

N470954005810 followed by a unit qualifier and the quantity

Package 70954-0058-10. 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 Prednisone Tablets, USP 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70954-058

What is NDC 70954-058?
70954-058 is the product NDC for Prednisone, Prednisone 5 mg/1 tablet, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 4 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?
ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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 211575

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

FDA NDC Directory listings under ANDA 211575
ProductStrengthForm · routeLabelerProduct NDC
PrednisonePrednisone 10 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-777
PrednisonePrednisone 10 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-401
PrednisonePrednisone 10 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3821
PrednisonePrednisone 5 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-413
PrednisonePrednisone 20 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-778
PrednisonePrednisone 50 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-779
PrednisonePrednisone 20 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3617
PrednisonePrednisone 20 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-448
PrednisonePrednisone 20 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3637
PrednisonePrednisone 20 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0486
PrednisonePrednisone 5 mg/1TabletOralBryant Ranch Prepack71335-1780
PrednisonePrednisone 20 mg/1TabletOralSt. Mary's Medical Park Pharmacy60760-797
Prednisone D/PPrednisone 5 mg/1TabletOralDirect_Rx72189-673
PrednisonePrednisone 50 mg/1TabletOralProficient Rx LP71205-665
PrednisonePrednisone 50 mg/1TabletOralA-S Medication Solutions50090-6225
PrednisonePrednisone 20 mg/1TabletOralProficient Rx LP71205-407
PrednisonePrednisone 50 mg/1TabletOralBryant Ranch Prepack71335-2160
PrednisonePrednisone 5 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-834
PrednisonePrednisone 10 mg/1TabletOralProficient Rx LP71205-421
PrednisonePrednisone 5 mg/1TabletOralProficient Rx LP82804-223

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