Prescription drug · ANDA
Prednisolone NDC 62135-437
Prednisolone 5 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-437-30 | 62135043730 | 30 TABLET in 1 BOTTLE (62135-437-30)Marketed from Mar 8, 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)
- Prednisolone
- Generic name (nonproprietary)
- prednisolone
- Active ingredients
- Prednisolone — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080531
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 62135-437_1b180b1a-f4e2-e1ee-e063-6294a90adc05SPL ID 1b180b1a-f4e2-e1ee-e063-6294a90adc05SPL set ID 2e965355-f7f2-4dd3-9c5c-1524c6f39c91RxCUI 198142UNII 9PHQ9Y1OLMUPC 0362135437305
- 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
N462135043730followed by a unit qualifier and the quantityPackage 62135-0437-30. 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.
About NDC 62135-437
- What is NDC 62135-437?
- 62135-437 is the product NDC for Prednisolone, Prednisolone 5 mg/1 tablet, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, 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?
- 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 RX, LLC | 62135-250 | 62135-0250-2462135-0250-3762135-0250-47 |
| Prednisoloneprednisolone oral | Prednisolone 15 mg/5mL | SolutionOral | Chartwell Governmental & Specialty RX, LLC. | 68999-250 | 68999-0250-24 |