Prescription drug · ANDA
Methylprednisolone NDC 42806-400
Methylprednisolone 4 mg/1 · Tablet · Oral · Epic Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-400-01 | 4280604000142806040001 | 100 TABLET in 1 BOTTLE (42806-400-01)Marketed from May 14, 2018 | |
| 42806-400-21 | 4280604002142806040021 | 1 BLISTER PACK in 1 CARTON (42806-400-21) / 21 TABLET in 1 BLISTER PACKMarketed from Feb 14, 2019 |
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)
- Methylprednisolone
- Generic name (nonproprietary)
- methylprednisolone
- Active ingredients
- Methylprednisolone — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Epic Pharma, LLCNDC labeler code 42806
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204072
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 42806-400_a7416892-37af-4d45-ab52-5e5700e6b3e5SPL ID a7416892-37af-4d45-ab52-5e5700e6b3e5SPL set ID b1908c2a-c596-4e2a-b2bd-0745d4fea31aRxCUI 259966, 762675UNII X4W7ZR7023UPC 0342806400210, 0342806400012
- 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
N442806040001followed by a unit qualifier and the quantityPackage 42806-0400-01. 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 Methylprednisolone 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 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: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require…
Excerpt only. Read the full label for complete information.
About NDC 42806-400
- What is NDC 42806-400?
- 42806-400 is the product NDC for Methylprednisolone, Methylprednisolone 4 mg/1 tablet, listed with the FDA by Epic Pharma, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methylprednisolone.
- What is the active ingredient?
- Methylprednisolone.
- Who is the labeler?
- Epic Pharma, LLC, NDC labeler code 42806. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Methylprednisolone?
- 48 other product NDCs are listed under this name. See all Methylprednisolone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methylprednisolone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | BluePoint Laboratories | 68001-624 | 68001-0624-01 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4213 | 70518-4213-00 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-961 | 60760-0961-21 |
| methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3622 | 70518-3622-01 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0230 | 80425-0230-01 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0231 | 80425-0231-01 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0255 | 80425-0255-01 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Direct_Rx | 72189-264 | 72189-0264-21 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7833 | 68788-7833-02 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2864 | 70518-2864-00 |
Other NDCs under ANDA 204072
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 |
|---|---|---|---|---|
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Tianjin Tianyao Pharmaceuticals Co., Ltd. | 57582-101 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-961 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5221 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7833 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Doc Rx | 69306-400 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2864 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Proficient Rx LP | 71205-453 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Direct_Rx | 72189-264 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-193 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0255 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | PHOENIX RX LLC | 85509-1400 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | HAWAII REPACK, INC. | 85534-0035 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Sportpharm LLC | 85766-037 |