What is NDC 0121-0885?

0121-0885 is the product NDC for Prednisolone, Prednisolone 15 mg/5mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.

PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Prednisolone?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Prednisolone NDC 0121-0885 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-0885Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-0885Add 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
0121-0885-08	00121088508	240 mL in 1 BOTTLE (0121-0885-08)Marketed from Sep 12, 2023
0121-0885-16	00121088516	480 mL in 1 BOTTLE (0121-0885-16)Marketed from Sep 12, 2023

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): Prednisolone
Generic name (nonproprietary): prednisolone
Active ingredients: Prednisolone — 15 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040571
Marketing start: Sep 12, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0121-0885_1166b85b-73c5-4a8f-bc41-f99b406d0ff5SPL ID 1166b85b-73c5-4a8f-bc41-f99b406d0ff5SPL set ID cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3RxCUI 283077UNII 9PHQ9Y1OLMUPC 0301210885082
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

N400121088508 followed by a unit qualifier and the quantity

Package 00121-0885-08. 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 Aug 19, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Prednisolone Oral Solution USP is 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 Nonsuppurative thyroiditis Hypercalcemia associated with cancer 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 (sel…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-0885

What is NDC 0121-0885?: 0121-0885 is the product NDC for Prednisolone, Prednisolone 15 mg/5mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Prednisolone.
What is the active ingredient?: Prednisolone.
Who is the labeler?: PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Prednisolone?: 11 other product NDCs are listed under this name. See all Prednisolone 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 Prednisolone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Prednisoloneprednisolone oral	Prednisolone 15 mg/5mL	SolutionOral	TRUPHARMA, LLC	52817-860	52817-0860-0852817-0860-16
Prednisoloneprednisolone oral	Prednisolone 15 mg/5mL	SolutionOral	Tulex Pharmaceuticals Inc	70404-077	70404-0077-1470404-0077-16
Prednisoloneprednisolone oral solution	Prednisolone 15 mg/5mL	SolutionOral	Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	23155-927	23155-0927-5123155-0927-52
Prednisolone	Prednisolone 5 mg/1	TabletOral	Hisun Pharmaceuticals USA, Inc.	42658-160	42658-0160-05
Prednisolone	Prednisolone 5 mg/1	TabletOral	Zhejiang Xianju Pharmaceutical Co., Ltd.	60722-5011	60722-5011-0060722-5011-01
Prednisolone	Prednisolone 15 mg/5mL	SolutionOral	A-S Medication Solutions	50090-7115	50090-7115-0050090-7115-01
Prednisolone	Prednisolone 5 mg/1	TabletOral	Aurobindo Pharma Limited	59651-491	59651-0491-0159651-0491-50
Prednisoloneprednisolone oral	Prednisolone 15 mg/5mL	SolutionOral	Chartwell Governmental & Specialty RX, LLC.	68999-250	68999-0250-24
Prednisoloneprednisolone oral	Prednisolone 15 mg/5mL	SolutionOral	Chartwell RX, LLC	62135-250	62135-0250-2462135-0250-3762135-0250-47
PrednisoLONE	Prednisolone 15 mg/5mL	SyrupOral	Lannett Company, Inc.	0527-5406	00527-5406-6800527-5406-70

All 12 Prednisolone NDCs

Other NDCs under ANDA 040571

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

FDA NDC Directory listings under ANDA 040571
Product	Strength	Form · route	Labeler	Product NDC
Prednisolone	Prednisolone 15 mg/5mL	SolutionOral	A-S Medication Solutions	50090-7115