Prescription drug · ANDA
prednisone NDC 68788-8166
Prednisone 10 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8166-1 | 68788816601 | 10 TABLET in 1 BOTTLE (68788-8166-1)Marketed from Sep 11, 2023 | |
| 68788-8166-2 | 68788816602 | 21 TABLET in 1 BOTTLE (68788-8166-2)Marketed from Apr 8, 2022 | |
| 68788-8166-3 | 68788816603 | 30 TABLET in 1 BOTTLE (68788-8166-3)Marketed from Apr 8, 2022 | |
| 68788-8166-4 | 68788816604 | 40 TABLET in 1 BOTTLE (68788-8166-4)Marketed from Sep 11, 2023 | |
| 68788-8166-5 | 68788816605 | 50 TABLET in 1 BOTTLE (68788-8166-5)Marketed from Sep 11, 2023 | |
| 68788-8166-6 | 68788816606 | 15 TABLET in 1 BOTTLE (68788-8166-6)Marketed from Sep 11, 2023 | |
| 68788-8166-7 | 68788816607 | 45 TABLET in 1 BOTTLE (68788-8166-7)Marketed from Sep 11, 2023 | |
| 68788-8166-8 | 68788816608 | 20 TABLET in 1 BOTTLE (68788-8166-8)Marketed from Sep 11, 2023 | |
| 68788-8166-9 | 68788816609 | 90 TABLET in 1 BOTTLE (68788-8166-9)Marketed from Sep 11, 2023 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208412
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68788-8166_c1619b4a-e3d3-4690-a9ee-cb0721ab898dSPL ID c1619b4a-e3d3-4690-a9ee-cb0721ab898dSPL set ID ce7663a7-4c91-4790-aa43-96f259b3bb18RxCUI 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
N468788816601followed by a unit qualifier and the quantityPackage 68788-8166-01. 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 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 cas…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208412
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 20 mg/1 | TabletOral | Medsource Pharmaceuticals | 45865-884 |
| prednisone | Prednisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2895 |
| prednisone | Prednisone 10 mg/1 | TabletOral | QPharma Inc | 42708-166 |
| prednisone | Prednisone 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-972 |
| prednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2069 |
| prednisone | Prednisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2079 |
| prednisone | Prednisone 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-6376 |
| prednisone | Prednisone 10 mg/1 | TabletOral | Sportpharm LLC | 85766-001 |
| prednisone | Prednisone 20 mg/1 | TabletOral | Sportpharm LLC | 85766-002 |
| prednisone | Prednisone 5 mg/1 | TabletOral | QPharma Inc | 42708-186 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | American Health Packaging | 60687-854 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Direct_Rx | 72189-430 |
| prednisone | Prednisone 5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0482 |
| prednisone | Prednisone 10 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0484 |
| prednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2122 |
| prednisone | Prednisone 20 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0487 |
| prednisone | Prednisone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2134 |
| prednisone | Prednisone 5 mg/1 | TabletOral | American Health Packaging | 60687-903 |
| prednisone | Prednisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2149 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | American Health Packaging | 60687-914 |
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