Prescription drug · ANDA
PredniSONE NDC 67046-1294
Prednisone 10 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1294-3 | 6704612940367046129403 | 30 TABLET in 1 BLISTER PACK (67046-1294-3)Marketed from Oct 6, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLCNDC labeler code 67046
- 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 67046-1294_5d2df738-602e-41c5-e063-6294a90ab3b8SPL ID 5d2df738-602e-41c5-e063-6294a90ab3b8
- 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
N467046129403followed by a unit qualifier and the quantityPackage 67046-1294-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 67046-1294
- What is NDC 67046-1294?
- 67046-1294 is the product NDC for PredniSONE, Prednisone 10 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, 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?
- Coupler LLC, NDC labeler code 67046. 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 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 |
| prednisone | Prednisone 5 mg/1 | TabletOral | Coupler LLC | 67046-1642 | 67046-1642-03 |
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 | PD-Rx Pharmaceuticals, Inc. | 43063-968 |
| 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 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3581 |
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