Prescription drug · ANDA
PredniSONE Tablets, USP, 10 mg (Prednisone) NDC 72789-475
Prednisone 10 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-475-01 | 72789047501 | 100 TABLET in 1 BOTTLE, PLASTIC (72789-475-01)Marketed from May 22, 2025 | |
| 72789-475-04 | 72789047504 | 4 TABLET in 1 BOTTLE, PLASTIC (72789-475-04)Marketed from Dec 24, 2025 | |
| 72789-475-12 | 72789047512 | 12 TABLET in 1 BOTTLE, PLASTIC (72789-475-12)Marketed from Jul 23, 2025 | |
| 72789-475-21 | 72789047521 | 21 TABLET in 1 BOTTLE, PLASTIC (72789-475-21)Marketed from Jun 24, 2025 | |
| 72789-475-30 | 72789047530 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-475-30)Marketed from Dec 16, 2025 | |
| 72789-475-40 | 72789047540 | 40 TABLET in 1 BOTTLE, PLASTIC (72789-475-40)Marketed from Sep 3, 2025 | |
| 72789-475-50 | 72789047550 | 50 TABLET in 1 BOTTLE, PLASTIC (72789-475-50)Marketed from Jun 12, 2025 | |
| 72789-475-95 | 72789047595 | 1000 TABLET in 1 BOTTLE, PLASTIC (72789-475-95)Marketed from May 22, 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 Tablets, USP, 10 mg
- Generic name (nonproprietary)
- prednisone
- Active ingredients
- Prednisone — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212629
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72789-475_4ddfc5f0-5f52-0667-e063-6294a90a0a83SPL ID 4ddfc5f0-5f52-0667-e063-6294a90a0a83SPL set ID 14d50f54-410b-45b2-a639-31498ceaf854RxCUI 198145UNII 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
N472789047501followed by a unit qualifier and the quantityPackage 72789-0475-01. 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)
INDICATIONS AND USAGE Prednisone tablets are 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 Hypercalcemia associated with cancer Nonsuppurative thyroiditis 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 …
Excerpt only. Read the full label for complete information.
About NDC 72789-475
- What is NDC 72789-475?
- 72789-475 is the product NDC for PredniSONE Tablets, USP, 10 mg (prednisone), Prednisone 10 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 8 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- PredniSONE Tablets, USP, 10 mg (PredniSONE).
- What is the active ingredient?
- Prednisone.
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for PredniSONE Tablets, USP, 10 mg?
- 7 other product NDCs are listed under this name. See all PredniSONE Tablets, USP, 10 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other PredniSONE Tablets, USP, 10 mg products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| PredniSONE Tablets, USP, 10 mgprednisone | Prednisone 10 mg/1 | TabletOral | Granulation Technology, Inc. | 63561-0121 | 63561-0121-0163561-0121-0263561-0121-05 |
| PredniSONE Tablets, USP, 10 mgprednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2736 | 71335-2736-0071335-2736-0171335-2736-02+7 more |
| PredniSONE Tablets, USP, 10 mgprednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2752 | 71335-2752-0071335-2752-0171335-2752-02+7 more |
| PredniSONE Tablets, USP, 10 mgprednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3044 | 71335-3044-01 |
| PredniSONE Tablets, USP, 10 mgprednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3045 | 71335-3045-01 |
| PredniSONE Tablets, USP, 10 mgprednisone | Prednisone 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-513 | 72789-0513-1072789-0513-2072789-0513-30 |
| PredniSONE Tablets, USP, 10 mgprednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2485 | 72162-2485-0072162-2485-01 |
Other NDCs under ANDA 212629
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
Showing 20 of 24.