Methylprednisolone Sodium Succinate
- Product NDC
- 63323-258
- 11-digit product format
- 633230258
- Labeler code
- 63323
- Product ID
- 63323-258_dc369096-3042-4942-9aeb-bbdf98f35bb8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHYLPREDNISOLONE SODIUM SUCCINATE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA040583
- Marketing category
- ANDA
- Marketing start
- 2004-11-30
- Substance
- METHYLPREDNISOLONE SODIUM SUCCINATE
- Active strength
- 125 mg/2mL
- 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
- Methylprednisolone Sodium Succinate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPREDNISOLONE SODIUM SUCCINATE | 125 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | LEC9GKY20K |
| Rxcui | 311659, 314099, 1743704 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-258-01 | Methylprednisolone Sodium Succinate | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 2 | | 7 |
| 63323-258-03 | Methylprednisolone Sodium Succinate | 25 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 25 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METHYLPREDNISOLONE SODIUM SUCCINATE | ACTIVE INGREDIENT | LEC9GKY20K | METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| METHYLPREDNISOLONE | ACTIVE MOIETY | X4W7ZR7023 | METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| SODIUM PHOSPHATE, DIBASIC ANHYDROUS | INACTIVE INGREDIENT | 22ADO53M6F | METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| SODIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | 22ADO53M6F | METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
| SODIUM PHOSPHATE, MONOBASIC ANHYDROUS | INACTIVE INGREDIENT | KH7I04HPUU | METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-258 | METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] | 7 | Current NDC, Legacy NDC, 2 package rows | 20230509_c5d22210-73c6-4697-a267-75e243508642.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 |
|---|
| 63323-258-01 | 63323025801 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | | Historical |
| 63323-258-03 | 63323025803 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-258-03) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-258-01) | | 2004-11-30 | 0000-00-00 | No | No | Current |