Prescription drug · ANDA
Prednisone delayed release (prednisone) NDC 43598-886
Prednisone 1 mg/1 · Tablet, Delayed release · Oral · Dr. Reddys Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-886-01 | 43598088601 | 1 BOTTLE in 1 CARTON (43598-886-01) / 100 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Dec 15, 2025 | |
| 43598-886-30 | 43598088630 | 1 BOTTLE in 1 CARTON (43598-886-30) / 30 TABLET, DELAYED RELEASE in 1 BOTTLEMarketed from Dec 15, 2025 |
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)
- Prednisone delayed release
- Generic name (nonproprietary)
- prednisone
- Active ingredients
- Prednisone — 1 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Dr. Reddys Laboratories Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219477
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 43598-886_a9e0d98c-c1bf-62b0-67b3-3b8f8313b408SPL ID a9e0d98c-c1bf-62b0-67b3-3b8f8313b408SPL set ID 01bdc479-1f1f-af94-837c-12e7e861321aRxCUI 1303125, 1303132UNII VB0R961HZT
- 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
N443598088601followed by a unit qualifier and the quantityPackage 43598-0886-01. 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)
Prednisone delayed-release tablets are indicated in the treatment of the following diseases or conditions: Prednisone delayed-release tablets are a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation ( 1 ) for the treatment of certain endocrine conditions ( 1 ) for palliation of certain neoplastic conditions ( 1 ) 1.1 Allergic Conditions Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adults and pediat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 219477
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 |
|---|---|---|---|---|
| Prednisone delayed releaseprednisone | Prednisone 1 mg/1 | Tablet, Delayed releaseOral | INA Pharmaceutics Inc | 74157-010 |
| Prednisone delayed releaseprednisone | Prednisone 2 mg/1 | Tablet, Delayed releaseOral | INA Pharmaceutics Inc | 74157-019 |
| Prednisone delayed releaseprednisone | Prednisone 2 mg/1 | Tablet, Delayed releaseOral | Dr. Reddys Laboratories Inc. | 43598-887 |