Prescription drug · ANDA
Prednisolone NDC 60722-5011
Prednisolone 5 mg/1 · Tablet · Oral · Zhejiang Xianju Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60722-5011-0 | 60722501100 | 100 TABLET in 1 BOTTLE (60722-5011-0)Marketed from Sep 1, 2024 | |
| 60722-5011-1 | 60722501101 | 1000 TABLET in 1 BOTTLE (60722-5011-1)Marketed from Sep 1, 2024 |
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)
- Prednisolone
- Generic name (nonproprietary)
- prednisolone
- Active ingredients
- Prednisolone — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218083
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 60722-5011_da9dfcf4-1631-4923-9536-72c27fc0b307SPL ID da9dfcf4-1631-4923-9536-72c27fc0b307SPL set ID 52e6e21d-94b8-41a0-8d13-371c0e66bceeRxCUI 198142UNII 9PHQ9Y1OLMUPC 0360722501101, 0360722501118
- 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
N460722501100followed by a unit qualifier and the quantityPackage 60722-5011-00. 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 AND USAGE 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 (selected cases may require low-dose maintenance therapy) Ankylosing spondy…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218083
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Prednisolone | Prednisolone 5 mg/1 | TabletOral | Hisun Pharmaceuticals USA, Inc. | 42658-160 |