What is NDC 10135-775?

10135-775 is the product NDC for Prednisone, Prednisone 2.5 mg/1 tablet, listed with the FDA by Marlex Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Marlex Pharmaceuticals, Inc., NDC labeler code 10135. 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?

282 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Prednisone NDC 10135-775 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)10135-775Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10135-0775Add 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 NDC	11-digit (billing)	Package	Copy
10135-775-01	10135077501	100 TABLET in 1 BOTTLE (10135-775-01)Marketed from Feb 1, 2023

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 — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Marlex Pharmaceuticals, Inc.NDC labeler code 10135
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211575
Marketing start: Feb 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 10135-775_441fcae7-8682-1a29-e063-6394a90a3881SPL ID 441fcae7-8682-1a29-e063-6394a90a3881SPL set ID f499197b-b9b7-1707-e053-2a95a90a0932RxCUI 198145, 198146, 198148, 312615, 312617UNII 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

N410135077501 followed by a unit qualifier and the quantity

Package 10135-0775-01. 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 Nov 21, 2025.

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 10135-775

What is NDC 10135-775?: 10135-775 is the product NDC for Prednisone, Prednisone 2.5 mg/1 tablet, listed with the FDA by Marlex Pharmaceuticals, Inc.. It has 1 package NDC, 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?: Marlex Pharmaceuticals, Inc., NDC labeler code 10135. 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?: 282 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
PredniSONE	Prednisone 20 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4182	68788-4182-0168788-4182-0268788-4182-03+3 more
prednisone	Prednisone 10 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-069	87441-0069-01
prednisone	Prednisone 50 mg/1	TabletOral	Coupler LLC	67046-1171	67046-1171-03
prednisone	Prednisone 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2582	55154-2582-00
prednisone	Prednisone 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4660	70518-4660-00
Prednisone	Prednisone 50 mg/1	TabletOral	Coupler LLC	67046-1379	67046-1379-03
Prednisone	Prednisone 20 mg/1	TabletOral	Cardinal Health 107, LLC	55154-2581	55154-2581-00
Prednisone	Prednisone 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4560	70518-4560-00
prednisone	Prednisone 5 mg/1	TabletOral	American Health Packaging	60687-903	60687-0903-01
prednisone	Prednisone 5 mg/1	TabletOral	Coupler LLC	67046-1642	67046-1642-03

All 283 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
Product	Strength	Form · route	Labeler	Product NDC
Prednisone	Prednisone 50 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-779
Prednisone	Prednisone 10 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3821
Prednisone	Prednisone 20 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0486
Prednisone	Prednisone 5 mg/1	TabletOral	Bryant Ranch Prepack	71335-1780
Prednisone	Prednisone 20 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3617
Prednisone D/P	Prednisone 5 mg/1	TabletOral	Direct_Rx	72189-673
Prednisone	Prednisone 20 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3637
Prednisone	Prednisone 5 mg/1	TabletOral	Proficient Rx LP	82804-223
Prednisone	Prednisone 5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-834
Prednisone	Prednisone 50 mg/1	TabletOral	Proficient Rx LP	71205-665
Prednisone	Prednisone 50 mg/1	TabletOral	Bryant Ranch Prepack	71335-2160
Prednisone	Prednisone 20 mg/1	TabletOral	Proficient Rx LP	71205-407
Prednisone	Prednisone 20 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-797
Prednisone	Prednisone 10 mg/1	TabletOral	Proficient Rx LP	71205-421
Prednisone	Prednisone 20 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-393
Prednisone	Prednisone 10 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-401
Prednisone	Prednisone 5 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-413
Prednisone	Prednisone 5 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-776
Prednisone	Prednisone 2.5 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	70954-057
Prednisone	Prednisone 5 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	70954-058

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