Prescription drug · ANDA
Prednisolone (Prednisolone oral) NDC 70404-077
Prednisolone 15 mg/5mL · Solution · Oral · Tulex Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70404-077-14 | 7040400771470404007714 | 240 mL in 1 BOTTLE (70404-077-14)Marketed from Jul 8, 2026 | |
| 70404-077-16 | 7040400771670404007716 | 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 IncNDC labeler code 70404
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219509
- Marketing start
- Listing expires
- 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
N470404007714followed by a unit qualifier and the quantityPackage 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 .
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 70404-077
- What is NDC 70404-077?
- 70404-077 is the product NDC for Prednisolone (prednisolone oral), Prednisolone 15 mg/5mL solution, listed with the FDA by Tulex Pharmaceuticals Inc. It has 2 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?
- Tulex Pharmaceuticals Inc, NDC labeler code 70404. 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 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 |
| PrednisoLONE | Prednisolone 15 mg/5mL | SyrupOral | Lannett Company, Inc. | 0527-5406 | 00527-5406-6800527-5406-70 |
Other NDCs under ANDA 219509
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 | Prednisolone 15 mg/5mL | SolutionOral | TRUPHARMA, LLC | 52817-860 |