Methylprednisolone acetate
- Product NDC
- 70121-1609
- 11-digit product format
- 701211609
- Labeler code
- 70121
- Product ID
- 70121-1609_924543a3-d04f-4c44-a2ee-008301b1f620
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylprednisolone acetate
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA216502
- Marketing category
- ANDA
- Marketing start
- 2023-11-10
- 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 | 1358610, 1358617 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70121-1609-1 | Methylprednisolone acetate | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SUSPENSION | 10 | | 10 |
| 70121-1609-1 | Methylprednisolone acetate | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 10 |
| 70121-1609-5 | Methylprednisolone acetate | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SUSPENSION | 10 | | 10 |
| 70121-1609-5 | Methylprednisolone acetate | 25 in 1 CARTON | INJECTION, SUSPENSION | 25 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70121-1609 | METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [AMNEAL PHARMACEUTICALS LLC] | 7 | Current NDC, 4 package rows | 20240805_de12f38c-ffa1-4d62-b9cb-238a263f6fea.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70121-1609-1 | 70121160901 | 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1609-1) / 10 mL in 1 VIAL, MULTI-DOSE | 2023-11-10 | No | No | Historical |
| 70121-1609-5 | 70121160905 | 25 VIAL, MULTI-DOSE in 1 CARTON (70121-1609-5) / 10 mL in 1 VIAL, MULTI-DOSE | 2023-11-10 | No | No | Historical |