Prescription drug · ANDA
Prednisone NDC 72789-413
Prednisone 5 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-413-21 | 7278904132172789041321 | 21 TABLET in 1 BOTTLE, PLASTIC (72789-413-21)Marketed from Jun 10, 2024 | |
| 72789-413-30 | 7278904133072789041330 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-413-30)Marketed from Jul 8, 2024 |
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
- Generic name (nonproprietary)
- prednisone
- Active ingredients
- Prednisone — 5 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 211575
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72789-413_57c408f8-6df2-2d75-e063-6294a90ab0dfSPL ID 57c408f8-6df2-2d75-e063-6294a90ab0dfSPL set ID 1a9f00ac-ec92-4d2c-e063-6394a90ac4f6RxCUI 312617UNII VB0R961HZTUPC 0372789413211
- 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
N472789041321followed by a unit qualifier and the quantityPackage 72789-0413-21. 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 & USAGE Prednisone Tablets, USP are indicated in the following conditions: 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 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 72789-413
- What is NDC 72789-413?
- 72789-413 is the product NDC for Prednisone, Prednisone 5 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- 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?
- 281 other product NDCs are listed under this name. See all Prednisone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prednisone 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 | Prednisone 10 mg/1 | TabletOral | Coupler LLC | 67046-1294 | 67046-1294-03 |
| PredniSONE | Prednisone 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4182 | 68788-4182-0168788-4182-0268788-4182-03+3 more |
| prednisone | Prednisone 10 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-069 | 87441-0069-01 |
| prednisone | Prednisone 50 mg/1 | TabletOral | Coupler LLC | 67046-1171 | 67046-1171-03 |
| prednisone | Prednisone 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2582 | 55154-2582-00 |
| prednisone | Prednisone 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4660 | 70518-4660-00 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | Coupler LLC | 67046-1379 | 67046-1379-03 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2581 | 55154-2581-00 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4560 | 70518-4560-00 |
| prednisone | Prednisone 5 mg/1 | TabletOral | American Health Packaging | 60687-903 | 60687-0903-01 |
Other NDCs under ANDA 211575
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 | Prednisone 10 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-777 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-401 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3821 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-778 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-779 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3617 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-448 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3637 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0486 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1780 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-797 |
| Prednisone D/P | Prednisone 5 mg/1 | TabletOral | Direct_Rx | 72189-673 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | Proficient Rx LP | 71205-665 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-6225 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Proficient Rx LP | 71205-407 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2160 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-834 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Proficient Rx LP | 71205-421 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Proficient Rx LP | 82804-223 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-359 |
Showing 20 of 28.