Epinastine Hydrochloride
- Product NDC
- 60505-0584
- 11-digit product format
- 605050584
- Labeler code
- 60505
- Product ID
- 60505-0584_838f525d-0f34-8f20-9364-7aaf36a42c32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Epinastine Hydrochloride
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Apotex Corp.
- Application
- ANDA090919
- Marketing category
- ANDA
- Marketing start
- 2011-10-31
- Marketing end
- 2021-03-01
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60505-0584-1 | 60505058401 | 1 BOTTLE, PLASTIC in 1 CARTON (60505-0584-1) > 5 mL in 1 BOTTLE, PLASTIC | 2011-10-31 | 2021-03-01 | No | No | Current |