Epinastine
- Product NDC
- 17478-911
- 11-digit product format
- 174780911
- Labeler code
- 17478
- Product ID
- 17478-911_b33db870-bbce-4ab7-9fc8-acf91aace213
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Epinastine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA204055
- Marketing category
- ANDA
- Marketing start
- 2017-05-05
- Marketing end
- 0000-00-00
- Substance
- EPINASTINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Adrenergic Agonists [MoA], Adrenergic Receptor Agonist [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 17478-911-05 | 17478091105 | 5 mL in 1 BOTTLE, DROPPER (17478-911-05) | 5 ml | 2017-05-05 | 0000-00-00 | No | No | Current |