methylprednisolone acetate
- Product NDC
- 25021-821
- 11-digit product format
- 250210821
- Labeler code
- 25021
- Product ID
- 25021-821_13e1ca54-4fc4-4e93-a52d-c9320865e3cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methylprednisolone acetate
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA201835
- Marketing category
- ANDA
- Marketing start
- 2021-11-15
- Substance
- METHYLPREDNISOLONE ACETATE
- Active strength
- 80 mg/mL
- 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 acetate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPREDNISOLONE ACETATE | 80 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 |
|---|
| 25021-821-05 | methylprednisolone acetate | 5 mL in 1 VIAL | INJECTION, SUSPENSION | 5 | | 9 |
| 25021-821-05 | methylprednisolone acetate | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-821 | METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [SAGENT PHARMACEUTICALS] | 9 | Current NDC, Legacy NDC, 2 package rows | 20220215_f98314ea-a4e4-4f78-987b-3e9b45a08bb4.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 |
|---|
| 25021-821-05 | 25021082105 | 1 VIAL in 1 CARTON (25021-821-05) / 5 mL in 1 VIAL | 1 vial | 2021-11-15 | 0000-00-00 | No | No | Current |