Prescription drug · ANDA
Prednisone NDC 0591-5052
Prednisone 5 mg/1 · Tablet · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-5052-01 | 00591505201 | 100 TABLET in 1 BOTTLE (0591-5052-01)Marketed from Jan 1, 1990 | |
| 0591-5052-10 | 00591505210 | 1000 TABLET in 1 BOTTLE (0591-5052-10)Marketed from Jan 1, 1990 | |
| 0591-5052-21 | 00591505221 | 1 BLISTER PACK in 1 CARTON (0591-5052-21) / 21 TABLET in 1 BLISTER PACKMarketed from May 25, 2016 | |
| 0591-5052-43 | 00591505243 | 1 BLISTER PACK in 1 CARTON (0591-5052-43) / 48 TABLET in 1 BLISTER PACKMarketed from May 25, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080356
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0591-5052_6e6cf2e7-c839-4c9f-a58a-fea5023fb432SPL ID 6e6cf2e7-c839-4c9f-a58a-fea5023fb432SPL set ID aa0b1582-6ef3-4697-9ea6-5391e6e57853RxCUI 198145, 312615, 312617, 763179, 763181, 763183, 763185UNII 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
N400591505201followed by a unit qualifier and the quantityPackage 00591-5052-01. 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 ca…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 080356
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 5 mg/1 | TabletOral | Proficient Rx LP | 63187-997 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | PharmPak, Inc. | 54348-506 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3537 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | QPharma, Inc. | 42708-114 |