methylprednisolone acetate
- Product NDC
- 68083-617
- Requested package NDC
- 68083-617-25
- 11-digit product format
- 680830617
- Labeler code
- 68083
- Product ID
- 68083-617_c5f61720-6b57-4514-b833-24ce74c1074c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methylprednisolone acetate
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
- Labeler
- Gland Pharma Limited
- Application
- ANDA219662
- Marketing category
- ANDA
- Marketing start
- 2026-11-02
- Substance
- METHYLPREDNISOLONE ACETATE
- Active strength
- 80 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- methylprednisolone acetate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPREDNISOLONE ACETATE | 80 mg/mL |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-617-25 | 68083061725 | 25 VIAL, SINGLE-DOSE in 1 CARTON (68083-617-25) / 1 mL in 1 VIAL, SINGLE-DOSE | 2026-11-02 | No | No | Current |