Prednisolone (prednisolone oral) NDC 70404-077

NDC codes

FDA NDC Directory

Product NDC (as listed)70404-077Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70404-0077Add 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
70404-077-14	70404007714	240 mL in 1 BOTTLE (70404-077-14)Marketed from Jul 8, 2026
70404-077-16	70404007716	480 mL in 1 BOTTLE (70404-077-16)Marketed from Jul 8, 2026

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): Prednisolone
Generic name (nonproprietary): prednisolone oral
Active ingredients: Prednisolone — 15 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Tulex Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219509
Marketing start: Jul 8, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 70404-077_561d8c9c-b67f-7fb2-e063-6394a90a0316SPL ID 561d8c9c-b67f-7fb2-e063-6394a90a0316SPL set ID 757b41c4-a0fe-4a09-8816-a4cdb7558f41RxCUI 283077UNII 9PHQ9Y1OLMUPC 0352817860163, 0352817860088
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

N470404007714 followed by a unit qualifier and the quantity

Package 70404-0077-14. 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 Jul 8, 2026.

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 (se…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 219509

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

FDA NDC Directory listings under ANDA 219509
Product	Strength	Form · route	Labeler	Product NDC
Prednisoloneprednisolone oral	Prednisolone 15 mg/5mL	SolutionOral	TRUPHARMA, LLC	52817-860