Prescription drug · NDA
Orapred ODT (Prednisolone sodium phosphate) NDC 59212-701
Prednisolone sodium phosphate 15 mg/1 · Tablet, Orally disintegrating · Oral · Advanz Pharma (US) Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59212-701-12 | 5921207011259212070112 | 2 BLISTER PACK in 1 CARTON (59212-701-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59212-701-06)Marketed from Jun 30, 2020 |
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)
- Orapred ODTSuffix: ODT
- Generic name (nonproprietary)
- prednisolone sodium phosphate
- Active ingredients
- Prednisolone sodium phosphate — 15 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Advanz Pharma (US) Corp.NDC labeler code 59212
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021959
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 59212-701_d172c0d5-b118-4433-92bd-05214976dd8fSPL ID d172c0d5-b118-4433-92bd-05214976dd8fSPL set ID 1e379543-c4cf-4e72-953b-db15b7f0c2a1RxCUI 643123, 643125, 643127, 647127, 668658, 668660UNII IV021NXA9J
- 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
N459212070112followed by a unit qualifier and the quantityPackage 59212-0701-12. 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)
Orapred ODT (prednisolone sodium phosphate orally disintegrating tablet) is indicated in the treatment of the following diseases or conditions: Orapred ODT is a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation ( 1 ) for the treatment of certain endocrine conditions ( 1 ) for palliation of certain neoplastic conditions ( 1 ) 1.1 Allergic Conditions Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adul…
Excerpt only. Read the full label for complete information.
About NDC 59212-701
- What is NDC 59212-701?
- 59212-701 is the product NDC for Orapred ODT (prednisolone sodium phosphate), Prednisolone sodium phosphate 15 mg/1 tablet, orally disintegrating, listed with the FDA by Advanz Pharma (US) Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Orapred ODT (Prednisolone sodium phosphate).
- What is the active ingredient?
- Prednisolone sodium phosphate.
- Who is the labeler?
- Advanz Pharma (US) Corp., NDC labeler code 59212. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Orapred ODT?
- 2 other product NDCs are listed under this name. See all Orapred ODT NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Orapred ODT products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Orapred ODTprednisolone sodium phosphate | Prednisolone sodium phosphate 10 mg/1 | Tablet, Orally disintegratingOral | Advanz Pharma (US) Corp. | 59212-700 | 59212-0700-12 |
| Orapred ODTprednisolone sodium phosphate | Prednisolone sodium phosphate 30 mg/1 | Tablet, Orally disintegratingOral | Advanz Pharma (US) Corp. | 59212-702 | 59212-0702-12 |
Other NDCs under NDA 021959
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 |
|---|---|---|---|---|
| Orapred ODTprednisolone sodium phosphate | Prednisolone sodium phosphate 10 mg/1 | Tablet, Orally disintegratingOral | Advanz Pharma (US) Corp. | 59212-700 |
| Orapred ODTprednisolone sodium phosphate | Prednisolone sodium phosphate 30 mg/1 | Tablet, Orally disintegratingOral | Advanz Pharma (US) Corp. | 59212-702 |
| prednisolone sodium phosphate ODTprednisolone sodium phosphate | Prednisolone sodium phosphate 10 mg/1 | Tablet, Orally disintegratingOral | Ingenus Pharmaceuticals, LLC | 50742-383 |
| prednisolone sodium phosphate ODTprednisolone sodium phosphate | Prednisolone sodium phosphate 15 mg/1 | Tablet, Orally disintegratingOral | Ingenus Pharmaceuticals, LLC | 50742-384 |
| prednisolone sodium phosphate ODTprednisolone sodium phosphate | Prednisolone sodium phosphate 30 mg/1 | Tablet, Orally disintegratingOral | Ingenus Pharmaceuticals, LLC | 50742-385 |