METHYLPREDNISOLONE
- Product NDC
- 57582-101
- 11-digit product format
- 575820101
- Labeler code
- 57582
- Product ID
- 57582-101_925bd0e3-3f69-411c-ad1e-7db010ec17be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHYLPREDNISOLONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Tianjin Tianyao Pharmaceuticals Co., Ltd.
- Application
- ANDA204072
- Marketing category
- ANDA
- Marketing start
- 2018-05-14
- Substance
- METHYLPREDNISOLONE
- Active strength
- 4 mg/1
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPREDNISOLONE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X4W7ZR7023 |
| Rxcui | 259966 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57582-101-01 | METHYLPREDNISOLONE | 100 in 1 BOTTLE | TABLET | 100 | | 16 |
| 57582-101-02 | METHYLPREDNISOLONE | 21 in 1 BLISTER PACK | TABLET | 21 | | 16 |
| 57582-101-02 | METHYLPREDNISOLONE | 1 in 1 CARTON | TABLET | 1 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57582-101 | METHYLPREDNISOLONE TABLET [TIANJIN TIANYAO PHARMACEUTICALS CO., LTD.] | 15 | Current NDC, Legacy NDC, 3 package rows | 20250514_e09eefd2-f423-40cb-87b6-3ee97e7f831b.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 |
|---|
| 57582-101-01 | 57582010101 | 100 TABLET in 1 BOTTLE (57582-101-01) | 100 tablet | 2018-05-14 | 0000-00-00 | No | No | Current |
| 57582-101-02 | 57582010102 | 1 BLISTER PACK in 1 CARTON (57582-101-02) / 21 TABLET in 1 BLISTER PACK | 1 blister pack | 2019-02-14 | 0000-00-00 | No | No | Current |