Prescription drug · ANDA
Prednisone NDC 0591-5443
Prednisone 20 mg/1 · Tablet · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-5443-01 | 00591544301 | 100 TABLET in 1 BOTTLE (0591-5443-01)Marketed from Jan 1, 1990 | |
| 0591-5443-05 | 00591544305 | 500 TABLET in 1 BOTTLE (0591-5443-05)Marketed from Jan 1, 1990 | |
| 0591-5443-10 | 00591544310 | 1000 TABLET in 1 BOTTLE (0591-5443-10)Marketed from Nov 11, 1993 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0591
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 085161
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0591-5443_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
N400591544301followed by a unit qualifier and the quantityPackage 00591-5443-01. 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.
About NDC 0591-5443
- What is NDC 0591-5443?
- 0591-5443 is the product NDC for Prednisone, Prednisone 20 mg/1 tablet, listed with the FDA by Actavis Pharma, 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?
- Actavis Pharma, Inc., NDC labeler code 0591. 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?
- 280 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 085161
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 | QPharma, Inc. | 42708-105 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-2786 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-2789 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-2804 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-242 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4685 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Proficient Rx LP | 71205-239 |