PREDNISOLONE ACETATE
- Product NDC
- 70748-332
- 11-digit product format
- 707480332
- Labeler code
- 70748
- Product ID
- 70748-332_8b7144d6-fff1-4afd-a80b-332ff7ed80a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- prednisolone acetate
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Lupin Pharmaceuticals, Inc.
- 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 |
|---|
| 70748-332-02 | PREDNISOLONE ACETATE | 5 mL in 1 BOTTLE | SUSPENSION/ DROPS | 5 | | 6 |
| 70748-332-02 | PREDNISOLONE ACETATE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 6 |
| 70748-332-03 | PREDNISOLONE ACETATE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 6 |
| 70748-332-03 | PREDNISOLONE ACETATE | 10 mL in 1 BOTTLE | SUSPENSION/ DROPS | 10 | | 6 |
| 70748-332-04 | PREDNISOLONE ACETATE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 6 |
| 70748-332-04 | PREDNISOLONE ACETATE | 15 mL in 1 BOTTLE | SUSPENSION/ DROPS | 15 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70748-332 | PREDNISOLONE ACETATE SUSPENSION/ DROPS [LUPIN PHARMACEUTICALS, INC.] | 5 | Current NDC, 6 package rows | 20250406_75fbeab1-ce8d-4999-a875-472174be5cc6.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 |
|---|
| 70748-332-02 | 70748033202 | 1 BOTTLE in 1 CARTON (70748-332-02) / 5 mL in 1 BOTTLE | 1 bottle | 2024-10-11 | No | No | Historical |
| 70748-332-03 | 70748033203 | 1 BOTTLE in 1 CARTON (70748-332-03) / 10 mL in 1 BOTTLE | 1 bottle | 2024-10-11 | No | No | Historical |
| 70748-332-04 | 70748033204 | 1 BOTTLE in 1 CARTON (70748-332-04) / 15 mL in 1 BOTTLE | 1 bottle | 2024-10-11 | No | No | Historical |