Prescription drug · ANDA
PredniSONE NDC 43063-968
Prednisone 5 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-968-21 | 4306309682143063096821 | 21 TABLET in 1 BOTTLE, PLASTIC (43063-968-21)Marketed from Apr 9, 2019 | |
| 43063-968-30 | 4306309683043063096830 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-968-30)Marketed from Apr 11, 2019 | |
| 43063-968-55 | 4306309685543063096855 | 55 TABLET in 1 BOTTLE, PLASTIC (43063-968-55)Marketed from Apr 16, 2019 |
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 43063
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080352
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 43063-968_3a21c358-f6b3-8e42-e063-6294a90a14cdSPL ID 3a21c358-f6b3-8e42-e063-6294a90a14cdSPL set ID f4500eb6-d24a-4247-83f4-99e73346e328RxCUI 312617UNII VB0R961HZTUPC 0343063968215
- 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
N443063096821followed by a unit qualifier and the quantityPackage 43063-0968-21. 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 Prednisone tablets and solutions 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 ca…
Excerpt only. Read the full label for complete information.
About NDC 43063-968
- What is NDC 43063-968?
- 43063-968 is the product NDC for PredniSONE, Prednisone 5 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 3 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 43063. 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 080352
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 | Hikma Pharmaceuticals USA Inc. | 0054-0017 |
| PredniSONE | Prednisone 20 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0018 |
| PredniSONE | Prednisone 50 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0019 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-4728 |
| PredniSONE | Prednisone 1 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-4741 |
| PredniSONE | Prednisone 2.5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-4742 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-8724 |
| PredniSONE | Prednisone 1 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-8739 |
| PredniSONE | Prednisone 2.5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-8740 |
| PredniSONE | Prednisone 10 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-9817 |
| PredniSONE | Prednisone 20 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-9818 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-9828 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6619 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6621 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6623 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-355 |
| PredniSONE | Prednisone 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-726 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-796 |
| PredniSONE | Prednisone 10 mg/1 | TabletOral | Coupler LLC | 67046-1294 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3581 |
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