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 PrepackNDC labeler code 63629
- 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.
About NDC 63629-1605
- What is NDC 63629-1605?
- 63629-1605 is the product NDC for Prednisone, Prednisone 5 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 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 5 mg/1 | TabletOral | Par Health USA, LLC | 0603-5337 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Par Health USA, LLC | 0603-5338 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6923 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-0439 |
| 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 | 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 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2146 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3564 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | American Health Packaging | 60687-122 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Proficient Rx LP | 63187-037 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Proficient Rx LP | 63187-066 |
| 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 | Aphena Pharma Solutions - Tennessee, LLC | 67544-399 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9551 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0305 |