Prescription drug · ANDA
Prednisone NDC 63629-1605
Prednisone 5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-1605-0 | 63629160500 | 42 TABLET in 1 BOTTLE (63629-1605-0)Marketed from Jun 8, 2010 | |
| 63629-1605-1 | 63629160501 | 30 TABLET in 1 BOTTLE (63629-1605-1)Marketed from Dec 7, 2004 | |
| 63629-1605-2 | 63629160502 | 78 TABLET in 1 BOTTLE (63629-1605-2)Marketed from Mar 18, 2005 | |
| 63629-1605-3 | 63629160503 | 36 TABLET in 1 BOTTLE (63629-1605-3)Marketed from Mar 12, 2010 | |
| 63629-1605-4 | 63629160504 | 21 TABLET in 1 BOTTLE (63629-1605-4)Marketed from Jan 10, 2005 | |
| 63629-1605-5 | 63629160505 | 15 TABLET in 1 BOTTLE (63629-1605-5)Marketed from Feb 11, 2005 | |
| 63629-1605-6 | 63629160506 | 100 TABLET in 1 BOTTLE (63629-1605-6)Marketed from Sep 15, 2008 | |
| 63629-1605-7 | 63629160507 | 20 TABLET in 1 BOTTLE (63629-1605-7)Marketed from Jun 15, 2009 | |
| 63629-1605-8 | 63629160508 | 10 TABLET in 1 BOTTLE (63629-1605-8)Marketed from Jan 18, 2010 | |
| 63629-1605-9 | 63629160509 | 90 TABLET in 1 BOTTLE (63629-1605-9)Marketed from Apr 20, 2010 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040256
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63629-1605_38b643dc-5d39-4618-8254-0ad17134e57aSPL ID 38b643dc-5d39-4618-8254-0ad17134e57aSPL set ID 290a91e5-22ae-4d62-ab34-39a3117002e2RxCUI 312617UNII 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
N463629160500followed by a unit qualifier and the quantityPackage 63629-1605-00. 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 are indicated in the following conditions: 1. 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 2. 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 040256
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 | A-S Medication Solutions | 50090-7023 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7024 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7025 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3564 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Par Health USA, LLC | 0603-5337 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6923 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2257 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2264 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | American Health Packaging | 60687-122 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | American Health Packaging | 60687-134 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-1001 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-1002 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Par Health USA, LLC | 0603-5338 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9551 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Proficient Rx LP | 63187-037 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2146 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Proficient Rx LP | 63187-066 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-399 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0305 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-0439 |