PREDNISOLONE ACETATE
- Product NDC
- 67296-2176
- 11-digit product format
- 672962176
- Labeler code
- 67296
- Product ID
- 67296-2176_44f6dd75-df38-6985-e063-6294a90a80cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- prednisolone acetate
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Redpharm Drug
- Application
- ANDA216935
- Marketing category
- ANDA
- Marketing start
- 2024-10-11
- 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 |
|---|
| 67296-2176-5 | PREDNISOLONE ACETATE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 2 |
| 67296-2176-5 | PREDNISOLONE ACETATE | 5 mL in 1 BOTTLE | SUSPENSION/ DROPS | 5 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67296-2176-5 | 67296217605 | 1 BOTTLE in 1 CARTON (67296-2176-5) / 5 mL in 1 BOTTLE | 1 bottle | 2024-10-11 | No | No | Historical |