Prescription drug · ANDA
Prednisolone (Prednisolone oral) NDC 62135-250
Prednisolone 15 mg/5mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-250-24 | 6213502502462135025024 | 2 TRAY in 1 BOX (62135-250-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-250-45)Marketed from May 31, 2024 | |
| 62135-250-37 | 6213502503762135025037 | 240 mL in 1 BOTTLE (62135-250-37)Marketed from Nov 20, 2022 | |
| 62135-250-47 | 6213502504762135025047 | 480 mL in 1 BOTTLE (62135-250-47)Marketed from Nov 20, 2022 |
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
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040323
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 62135-250_19febba3-956f-d1a9-e063-6394a90afda5SPL ID 19febba3-956f-d1a9-e063-6394a90afda5SPL set ID aa40f582-cced-4e6e-90f0-10ab310ab2a7RxCUI 283077UNII 9PHQ9Y1OLMUPC 0362135250379, 0362135250478
- 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
N462135025024followed by a unit qualifier and the quantityPackage 62135-0250-24. 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 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.
About NDC 62135-250
- What is NDC 62135-250?
- 62135-250 is the product NDC for Prednisolone (prednisolone oral), Prednisolone 15 mg/5mL solution, listed with the FDA by Chartwell RX, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prednisolone (Prednisolone oral).
- What is the active ingredient?
- Prednisolone.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. 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.
Related NDCs: other Prednisolone products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | PAI Holdings, LLC dba PAI Pharma | 0121-0885 | 00121-0885-0800121-0885-16 |
| 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 |
| PrednisoLONE | Prednisolone 15 mg/5mL | SyrupOral | Lannett Company, Inc. | 0527-5406 | 00527-5406-6800527-5406-70 |
Other NDCs under ANDA 040323
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 |
|---|---|---|---|---|
| Prednisoloneprednisolone oral solution | Prednisolone 15 mg/5mL | SolutionOral | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | 23155-927 |
| Prednisoloneprednisolone oral | Prednisolone 15 mg/5mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-250 |