PREDNISOLONE ACETATE
- Product NDC
- 50090-7539
- 11-digit product format
- 500907539
- Labeler code
- 50090
- Product ID
- 50090-7539_af502300-c29e-405b-bb6f-f125d432a2c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- prednisolone acetate
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- A-S Medication Solutions
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PREDNISOLONE ACETATE
- Listing expiration
- 2027-12-31
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 |
|---|
| 50090-7539-0 | PREDNISOLONE ACETATE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 3 |
| 50090-7539-0 | PREDNISOLONE ACETATE | 5 mL in 1 BOTTLE | SUSPENSION/ DROPS | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-7539 | PREDNISOLONE ACETATE SUSPENSION/ DROPS [A-S MEDICATION SOLUTIONS] | 1 | Current NDC, 2 package rows | 20250425_f0e1b691-73ff-49ee-8a3c-71769b284ab8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7539-0 | 50090753900 | 1 BOTTLE in 1 CARTON (50090-7539-0) / 5 mL in 1 BOTTLE | 1 bottle | 2025-04-22 | No | No | Historical |