METHYLPREDNISOLONE ACETATE
- Product NDC
- 0781-3522
- 11-digit product format
- 007813522
- Labeler code
- 0781
- Product ID
- 0781-3522_ab8910e5-0b8c-4057-a95d-4519ce85835b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHYLPREDNISOLONE ACETATE
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
- Labeler
- Sandoz Inc.
- Application
- ANDA214870
- Marketing category
- ANDA
- Marketing start
- 2024-03-14
- Substance
- METHYLPREDNISOLONE ACETATE
- Active strength
- 40 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 | 40 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 |
|---|
| 0781-3522-75 | Physicians EZ Use M-pred | 1 in 1 CARTON | INJECTION, SUSPENSION | | 40 mg in 1mL | 13 |
| 0781-3522-75 | Physicians EZ Use M-pred | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SUSPENSION | 5 mL | 40 mg in 1mL | 13 |
| 0781-3522-70 | METHYLPREDNISOLONE ACETATE | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 7 |
| 0781-3522-70 | METHYLPREDNISOLONE ACETATE | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SUSPENSION | 10 | | 7 |
| 0781-3522-75 | METHYLPREDNISOLONE ACETATE | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SUSPENSION | 5 | | 7 |
| 0781-3522-75 | METHYLPREDNISOLONE ACETATE | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BUPIVACAINE HYDROCHLORIDE | ACTIVE INGREDIENT | 7TQO7W3VT8 | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
| METHYLPREDNISOLONE ACETATE | ACTIVE INGREDIENT | 43502P7F0P | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
| POVIDONE-IODINE | ACTIVE INGREDIENT | 85H0HZU99M | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
| BUPIVACAINE | ACTIVE MOIETY | Y8335394RO | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
| IODINE | ACTIVE MOIETY | 9679TC07X4 | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
| METHYLPREDNISOLONE | ACTIVE MOIETY | X4W7ZR7023 | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
| SODIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 3980JIH2SW | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [MEDCHEM MANUFACTURING INC. DBA ENOVACHEM] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-3522 | PHYSICIANS EZ USE M-PRED (METHYLPREDNISOLONE ACETATE, BUPIVACAINE HYDROCHLORIDE, POVIDONE-IODINE) KIT [ASCLEMED USA, INC.] | 13 | Current NDC | 20241101_dec92845-e713-42a3-83a7-3a48920b7eed.zip |
| 0781-3522 | METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [SANDOZ INC.] | 7 | Current NDC, 4 package rows | 20240316_a363f0cd-9c8e-4622-9271-171706846b96.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0781-3522-70 | 00781352270 | 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3522-70) / 10 mL in 1 VIAL, MULTI-DOSE | 2024-03-14 | No | No | Current |
| 0781-3522-75 | 00781352275 | 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3522-75) / 5 mL in 1 VIAL, MULTI-DOSE | 2024-03-14 | No | No | Current |