Methylprednisolone
- Product NDC
- 21695-080
- 11-digit product format
- 216950080
- Labeler code
- 21695
- Product ID
- 21695-080_98d480de-4089-477f-a049-0e09c59c5332
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylprednisolone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA040189
- Marketing category
- ANDA
- Marketing start
- 1997-10-31
- Marketing end
- 0000-00-00
- Substance
- METHYLPREDNISOLONE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b3918abe-5cd1-b0ce-abd7-2dd6732cde26 | Product name | 5 | 20260128 |
| e1637c7c-52c4-49a3-b36b-61be755aab29 | Product name | 4 | 20230717 |
| 9eb3e96d-a1d4-4de3-aa3d-a629eea44815 | Product name | 4 | 20220316 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-080-21 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4c5c-48b1-e053-8cdaa90a720a | METHYLPREDNISOLONE TABLETS, USP Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-080-21 | Methylprednisolone | 21 in 1 BOTTLE | TABLET | 21 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-080-21 | EA - Each | 21695-080 | 4cf306d4-2ccf-4951-a55b-6ce7b35cb5ec | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Methylprednisolone | ACTIVE INGREDIENT | X4W7ZR7023 | METHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| Methylprednisolone | ACTIVE MOIETY | X4W7ZR7023 | METHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | METHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | METHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| Magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | METHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| Sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | METHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | METHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | METHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 762675 | {21 (methylprednisolone 4 MG Oral Tablet) } Pack | GPCK | 6beebbfd-4846-49ec-8f5b-62e2c23c468c | 1 |
| 259966 | methylPREDNISolone 4 MG Oral Tablet | PSN | 6beebbfd-4846-49ec-8f5b-62e2c23c468c | 1 |
| 762675 | methylPREDNISolone 4 MG Tablet 6 Day 21 Count Pack | PSN | 6beebbfd-4846-49ec-8f5b-62e2c23c468c | 1 |
| 259966 | methylprednisolone 4 MG Oral Tablet | SCD | 6beebbfd-4846-49ec-8f5b-62e2c23c468c | 1 |
| 762675 | methylprednisolone 4 MG Oral Tablet 21 Count Pack | SY | 6beebbfd-4846-49ec-8f5b-62e2c23c468c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-080-21 | 21695008021 | 21 in 1 BOTTLE | Historical |