Prescription drug · ANDA
Prednisone NDC 70954-059
Prednisone 10 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-059-10 | 70954005910 | 100 TABLET in 1 BOTTLE (70954-059-10)Marketed from Nov 15, 2019 | |
| 70954-059-20 | 70954005920 | 1000 TABLET in 1 BOTTLE (70954-059-20)Marketed from Nov 15, 2019 | |
| 70954-059-30 | 70954005930 | 1 BLISTER PACK in 1 BOX (70954-059-30) / 21 TABLET in 1 BLISTER PACKMarketed from May 28, 2020 | |
| 70954-059-40 | 70954005940 | 1 BLISTER PACK in 1 BOX (70954-059-40) / 48 TABLET in 1 BLISTER PACKMarketed from May 28, 2020 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- 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 70954-059_f662b658-7133-468c-b35a-ed6083cbff91SPL ID f662b658-7133-468c-b35a-ed6083cbff91SPL set ID f05eb734-07e7-491c-b2e9-aae340e03750RxCUI 198145, 198146, 198148, 312615, 312617, 763179, 763181, 763183, 763185UNII VB0R961HZTUPC 0370954061106, 0370954057109
- 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
N470954005910followed by a unit qualifier and the quantityPackage 70954-0059-10. 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.
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 50 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-779 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1780 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3617 |
| Prednisone D/P | Prednisone 5 mg/1 | TabletOral | Direct_Rx | 72189-673 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0486 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-834 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | Proficient Rx LP | 71205-665 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Proficient Rx LP | 71205-407 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2160 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-797 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Proficient Rx LP | 71205-421 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Proficient Rx LP | 82804-223 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-393 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-401 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-413 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3637 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-058 |
| Prednisone | Prednisone 2.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-057 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-060 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-061 |
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