Orapred
- Product NDC
- 59212-700
- 11-digit product format
- 592120700
- Labeler code
- 59212
- Product ID
- 59212-700_d172c0d5-b118-4433-92bd-05214976dd8f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- prednisolone sodium phosphate
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Advanz Pharma (US) Corp.
- Application
- NDA021959
- Marketing category
- NDA
- Marketing start
- 2006-06-01
- Substance
- PREDNISOLONE SODIUM PHOSPHATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Orapred
- Brand name suffix
- ODT
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREDNISOLONE SODIUM PHOSPHATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IV021NXA9J |
| Rxcui | 643123, 643125, 643127, 647127, 668658, 668660 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59212-700-06 | OrapredODT | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | | 12 |
| 59212-700-12 | OrapredODT | 2 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 2 | | 12 |
| 59212-700-48 | OrapredODT | 8 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 8 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PREDNISOLONE SODIUM PHOSPHATE | ACTIVE INGREDIENT | IV021NXA9J | ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.] | 2 | |
| PREDNISOLONE | ACTIVE MOIETY | 9PHQ9Y1OLM | ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.] | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.] | 2 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.] | 2 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.] | 2 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [CONCORDIA PHARMACEUTICALS INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59212-700 | ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) TABLET, ORALLY DISINTEGRATING [ADVANZ PHARMA (US) CORP.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20250430_1e379543-c4cf-4e72-953b-db15b7f0c2a1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59212-700-06 | 59212070006 | 6 in 1 BLISTER PACK | | | | | | Historical |
| 59212-700-12 | 59212070012 | 2 BLISTER PACK in 1 CARTON (59212-700-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59212-700-06) | 2 blister pack | 2020-06-30 | 0000-00-00 | No | No | Current |
| 59212-700-48 | 59212070048 | 8 BLISTER PACK in 1 CARTON (59212-700-48) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59212-700-06) | 8 blister pack | 2006-06-01 | 0000-00-00 | No | No | Current |