prednisolone acetate
- Product NDC
- 60219-2552
- 11-digit product format
- 602192552
- Labeler code
- 60219
- Product ID
- 60219-2552_b184f928-3c7a-46a0-9c67-7d2946a37868
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- prednisolone acetate
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA218256
- Marketing category
- ANDA
- Marketing start
- 2025-06-13
- Substance
- PREDNISOLONE ACETATE
- Active strength
- 10 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
- prednisolone acetate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREDNISOLONE ACETATE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8B2807733D |
| Rxcui | 1376336 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60219-2552-1 | prednisolone acetate | 15 mL in 1 BOTTLE, PLASTIC | SUSPENSION/ DROPS | 15 | | 7 |
| 60219-2552-1 | prednisolone acetate | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 7 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 60219-2552-1 | 60219255201 | 1 BOTTLE, PLASTIC in 1 CARTON (60219-2552-1) / 15 mL in 1 BOTTLE, PLASTIC | 2025-06-13 | No | No | Current |