Loteprednol Etabonate
- Product NDC
- 17478-830
- 11-digit product format
- 174780830
- Labeler code
- 17478
- Product ID
- 17478-830_9a817ab3-25b6-4ad2-a27b-4e1ef4d25308
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Loteprednol Etabonate
- Dosage form
- GEL
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA212080
- Marketing category
- ANDA
- Marketing start
- 2021-02-10
- Marketing end
- 0000-00-00
- Substance
- LOTEPREDNOL ETABONATE
- Active strength
- 5 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17478-830 | LOTEPREDNOL ETABONATE GEL [AKORN] | 6 | Legacy NDC | 20220914_cbb76d1a-e26e-4d46-b4e7-fcd5785637e7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 17478-830-05 | 17478083005 | 1 BOTTLE, DROPPER in 1 CARTON (17478-830-05) > 5 g in 1 BOTTLE, DROPPER | 2021-02-10 | 0000-00-00 | No | No | Current |