PREDNISOLONE ACETATE
- Product NDC
- 76420-204
- 11-digit product format
- 764200204
- Labeler code
- 76420
- Product ID
- 76420-204_d1fbb852-8bc5-7a0e-e053-2a95a90a2d8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- prednisolone acetate
- Dosage form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Asclemed USA, Inc.
- Application
- NDA017011
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 1997-08-19
- 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 |
|---|
| 76420-204-05 | PREDNISOLONE ACETATE | 1 in 1 CARTON | SUSPENSION/ DROPS | 1 | | 1 |
| 76420-204-05 | PREDNISOLONE ACETATE | 5 mL in 1 BOTTLE, DROPPER | SUSPENSION/ DROPS | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-204 | PREDNISOLONE ACETATE SUSPENSION/ DROPS [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20211201_232e40a5-17c5-4cf3-9e3b-110a194ad4be.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76420-204-05 | 76420020405 | 1 BOTTLE, DROPPER in 1 CARTON (76420-204-05) / 5 mL in 1 BOTTLE, DROPPER | 2021-11-30 | 0000-00-00 | No | No | Current |