Prescription drug · ANDA
Prednisone NDC 61919-365
Prednisone 5 mg/1 · Tablet · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-365-21 | 61919036521 | 21 TABLET in 1 DOSE PACK (61919-365-21)Marketed from Jan 1, 2014 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- DIRECT RXNDC labeler code 61919
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040584
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 61919-365_4d3fa8d2-31a1-759a-e063-6294a90a0267SPL ID 4d3fa8d2-31a1-759a-e063-6294a90a0267SPL set ID 2a053775-6f6a-455e-b9a8-8b60e6062db3RxCUI 312617, 763181UNII 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
N461919036521followed by a unit qualifier and the quantityPackage 61919-0365-21. 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 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 Nonsuppurative thyroiditis Hypercalcemia associated with canceR 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 may require low-dose maintenance therapy) Ankylosing spondylitis Acu…
Excerpt only. Read the full label for complete information.
About NDC 61919-365
- What is NDC 61919-365?
- 61919-365 is the product NDC for Prednisone, Prednisone 5 mg/1 tablet, listed with the FDA by DIRECT RX. It has 1 package NDC, 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?
- DIRECT RX, NDC labeler code 61919. 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?
- 282 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 040584
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 1 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1169 |
| Prednisone | Prednisone 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3129 |
| Prednisone | Prednisone 1 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2254 |
| Prednisone | Prednisone 1 mg/1 | TabletOral | Par Health USA, LLC | 0603-5335 |