Methylprednisolone Acetate
- Product NDC
- 21695-849
- 11-digit product format
- 216950849
- Labeler code
- 21695
- Product ID
- 21695-849_faf608f3-a13d-4969-b1a6-bb0bc1de2a8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylprednisolone Acetate
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; PARENTERAL; SOFT TISSUE
- Labeler
- Rebel Distributors Corp
- Application
- ANDA040794
- Marketing category
- ANDA
- Marketing start
- 2009-03-05
- Marketing end
- 0000-00-00
- Substance
- METHYLPREDNISOLONE ACETATE
- Active strength
- 40 mg/mL
- 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 |
|---|---|---|---|---|---|
| 21695-849-10 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4923-48b1-e053-8cdaa90a720a | MethylPREDNISolone Acetate Injectable Suspension, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-849-10 | Methylprednisolone Acetate | 10 mL in 1 BOTTLE | INJECTION, SUSPENSION | 10 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-849-10 | ML - Milliliter | 21695-849 | 7e0cf893-655a-47d1-975d-5e7c777e81fc | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METHYLPREDNISOLONE ACETATE | ACTIVE INGREDIENT | 43502P7F0P | METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| METHYLPREDNISOLONE | ACTIVE MOIETY | X4W7ZR7023 | METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1358610 | methylPREDNISolone acetate 40 MG/ML Injectable Suspension | PSN | faf608f3-a13d-4969-b1a6-bb0bc1de2a8e | 1 |
| 1358617 | methylPREDNISolone acetate 80 MG/ML Injectable Suspension | PSN | faf608f3-a13d-4969-b1a6-bb0bc1de2a8e | 1 |
| 1358610 | methylprednisolone acetate 40 MG/ML Injectable Suspension | SCD | faf608f3-a13d-4969-b1a6-bb0bc1de2a8e | 1 |
| 1358617 | methylprednisolone acetate 80 MG/ML Injectable Suspension | SCD | faf608f3-a13d-4969-b1a6-bb0bc1de2a8e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-849-10 | 21695084910 | 10 mL in 1 BOTTLE | 10 ml | Historical |