Methylprednisolone acetate
- Product NDC
- 60219-1574
- 11-digit product format
- 602191574
- Labeler code
- 60219
- Product ID
- 60219-1574_15d5342a-3521-4c06-b5d9-4218e5a067f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylprednisolone acetate
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA210043
- Marketing category
- ANDA
- Marketing start
- 2022-04-10
- Substance
- METHYLPREDNISOLONE ACETATE
- Active strength
- 80 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 | 80 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 |
|---|
| 60219-1574-1 | Methylprednisolone acetate | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 1 | | 5 |
| 60219-1574-1 | Methylprednisolone acetate | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 5 |
| 60219-1574-5 | Methylprednisolone acetate | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 1 | | 5 |
| 60219-1574-5 | Methylprednisolone acetate | 25 in 1 CARTON | INJECTION, SUSPENSION | 25 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60219-1574 | METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [AMNEAL PHARMACEUTICALS NY LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250108_8ea42650-21cd-49e4-92c8-48f2eeaf95bc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60219-1574-1 | 60219157401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (60219-1574-1) / 1 mL in 1 VIAL, SINGLE-DOSE | 2022-04-10 | 0000-00-00 | No | No | Current |
| 60219-1574-5 | 60219157405 | 25 VIAL, SINGLE-DOSE in 1 CARTON (60219-1574-5) / 1 mL in 1 VIAL, SINGLE-DOSE | 2022-04-10 | 0000-00-00 | No | No | Current |