Methylprednisolone Acetate
- Product NDC
- 65145-192
- 11-digit product format
- 651450192
- Labeler code
- 65145
- Product ID
- 65145-192_23f98766-7571-49cb-8c1a-58fabba53965
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylprednisolone Acetate
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
- Labeler
- Caplin Steriles Limited
- Application
- ANDA220556
- Marketing category
- ANDA
- Marketing start
- 2026-02-06
- Substance
- METHYLPREDNISOLONE ACETATE
- Active strength
- 40 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Methylprednisolone Acetate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPREDNISOLONE ACETATE | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 43502P7F0P |
| Rxcui | 1743779, 1743855 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65145-192-01 | Methylprednisolone Acetate | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 1 | | 1 |
| 65145-192-25 | Methylprednisolone Acetate | 25 in 1 CARTON | INJECTION, SUSPENSION | 25 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65145-192-01 | 65145019201 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | Historical |
| 65145-192-25 | 65145019225 | 25 VIAL, SINGLE-DOSE in 1 CARTON (65145-192-25) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-192-01) | | 2026-02-06 | No | No | Historical |