OMNIPRED
- Product NDC
- 0065-0638
- 11-digit product format
- 000650638
- Labeler code
- 0065
- Product ID
- 0065-0638_00c60dec-b63c-43ac-9f87-88aeff333136
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- prednisolone acetate
- Dosage form
- SUSPENSION
- Route
- OPHTHALMIC
- Labeler
- Alcon Laboratories, Inc.
- Application
- NDA017469
- Marketing category
- NDA
- Marketing start
- 2007-11-06
- Marketing end
- 2021-05-31
- Substance
- PREDNISOLONE ACETATE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0065-0638-25 | 00065063825 | 10 mL in 1 BOTTLE, PLASTIC (0065-0638-25) | 10 ml | 2007-11-06 | 2021-05-31 | No | No | Current |