Prescription drug · ANDA
prednisone NDC 64380-785
Prednisone 20 mg/1 · Tablet · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-785-01 | 64380078501 | 10 BLISTER PACK in 1 CARTON (64380-785-01) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 1, 2021 | |
| 64380-785-06 | 64380078506 | 100 TABLET in 1 BOTTLE, PLASTIC (64380-785-06)Marketed from Sep 1, 2021 | |
| 64380-785-07 | 64380078507 | 500 TABLET in 1 BOTTLE, PLASTIC (64380-785-07)Marketed from Sep 1, 2021 | |
| 64380-785-08 | 64380078508 | 1000 TABLET in 1 BOTTLE, PLASTIC (64380-785-08)Marketed from Sep 1, 2021 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208412
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 64380-785_bdf0b63b-7d6e-4799-be31-cdbf94e02145SPL ID bdf0b63b-7d6e-4799-be31-cdbf94e02145SPL set ID 2ef05381-faad-4e0f-b58d-9f2236a04a2cRxCUI 198145, 198148, 312615UNII VB0R961HZTUPC 0364380949060, 0364380785064, 0364380784067
- 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
N464380078501followed by a unit qualifier and the quantityPackage 64380-0785-01. 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 cas…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208412
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 | Medsource Pharmaceuticals | 45865-884 |
| prednisone | Prednisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2895 |
| prednisone | Prednisone 10 mg/1 | TabletOral | QPharma Inc | 42708-166 |
| prednisone | Prednisone 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-972 |
| prednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2069 |
| prednisone | Prednisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2079 |
| prednisone | Prednisone 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-6376 |
| prednisone | Prednisone 10 mg/1 | TabletOral | Sportpharm LLC | 85766-001 |
| prednisone | Prednisone 20 mg/1 | TabletOral | Sportpharm LLC | 85766-002 |
| prednisone | Prednisone 5 mg/1 | TabletOral | QPharma Inc | 42708-186 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | American Health Packaging | 60687-854 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Direct_Rx | 72189-430 |
| prednisone | Prednisone 5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0482 |
| prednisone | Prednisone 10 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0484 |
| prednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2122 |
| prednisone | Prednisone 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8166 |
| prednisone | Prednisone 20 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0487 |
| prednisone | Prednisone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2134 |
| prednisone | Prednisone 5 mg/1 | TabletOral | American Health Packaging | 60687-903 |
| prednisone | Prednisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2149 |
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