methylprednisolone
- Product NDC
- 68382-917
- 11-digit product format
- 683820917
- Labeler code
- 68382
- Product ID
- 68382-917_6cebff10-362f-41a7-8f66-3d9e878760fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methylprednisolone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA206751
- Marketing category
- ANDA
- Marketing start
- 2018-05-01
- Substance
- METHYLPREDNISOLONE
- Active strength
- 8 mg/1
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPREDNISOLONE | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X4W7ZR7023 |
| Rxcui | 197971, 197973, 259966, 328161, 762675 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-917-01 | methylprednisolone | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 68382-917-05 | methylprednisolone | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
| 68382-917-11 | methylprednisolone | 25 in 1 BOTTLE | TABLET | 25 | | 8 |
| 68382-917-30 | methylprednisolone | 10 in 1 BLISTER PACK | TABLET | 10 | | 8 |
| 68382-917-77 | methylprednisolone | 10 in 1 CARTON | TABLET | 10 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-917 | METHYLPREDNISOLONE TABLET [ZYDUS PHARMACEUTICALS USA INC.] | 7 | Current NDC, Legacy NDC, 5 package rows | 20240701_eaa9c932-c659-4ef6-bf5a-186545d87320.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 |
|---|
| 68382-917-01 | 68382091701 | 100 TABLET in 1 BOTTLE (68382-917-01) | 100 tablet | 2018-05-01 | 0000-00-00 | No | No | Current |
| 68382-917-05 | 68382091705 | 500 TABLET in 1 BOTTLE (68382-917-05) | 500 tablet | 2018-05-01 | 0000-00-00 | No | No | Current |
| 68382-917-11 | 68382091711 | 25 TABLET in 1 BOTTLE (68382-917-11) | 25 tablet | 2018-05-01 | 0000-00-00 | No | No | Current |
| 68382-917-30 | 68382091730 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68382-917-77 | 68382091777 | 10 BLISTER PACK in 1 CARTON (68382-917-77) / 10 TABLET in 1 BLISTER PACK (68382-917-30) | 10 blister pack | 2018-05-01 | 0000-00-00 | No | No | Current |