Prescription drug · ANDA
prednisone NDC 70518-3540
Prednisone 20 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3540-0 | 70518354000 | 30 TABLET in 1 BLISTER PACK (70518-3540-0)Marketed from Sep 26, 2022 | |
| 70518-3540-2 | 70518354002 | 10 TABLET in 1 BLISTER PACK (70518-3540-2)Marketed from Apr 13, 2025 | |
| 70518-3540-3 | 70518354003 | 30 TABLET in 1 BLISTER PACK (70518-3540-3)Marketed from May 16, 2025 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213386
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70518-3540_58c8d276-3bd4-34c7-e063-6394a90a69c2SPL ID 58c8d276-3bd4-34c7-e063-6394a90a69c2SPL set ID e47a0448-331f-4846-8e63-c52c3afa274bRxCUI 312615UNII 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
N470518354000followed by a unit qualifier and the quantityPackage 70518-3540-00. 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 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 may requir…
Excerpt only. Read the full label for complete information.
About NDC 70518-3540
- What is NDC 70518-3540?
- 70518-3540 is the product NDC for prednisone, Prednisone 20 mg/1 tablet, listed with the FDA by REMEDYREPACK 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 213386
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 | A-S Medication Solutions | 50090-6122 |
| prednisone | Prednisone 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-6123 |
| prednisone | Prednisone 20 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 60219-1708 |
| prednisone | Prednisone 10 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 60219-1707 |
| prednisone | Prednisone 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4354 |
| prednisone | Prednisone 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8440 |
| prednisone | Prednisone 20 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8441 |
| prednisone | Prednisone 20 mg/1 | TabletOral | Proficient Rx LP | 71205-797 |
| prednisone | Prednisone 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-6259 |
| prednisone | Prednisone 10 mg/1 | TabletOral | Proficient Rx LP | 71205-818 |
| prednisone | Prednisone 20 mg/1 | TabletOral | Redpharm Drug | 67296-2081 |
| prednisone | Prednisone 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7369 |
| prednisone | Prednisone 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7371 |
| prednisone | Prednisone 10 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-069 |