Epinastine Hydrochloride
- Product NDC
- 51991-836
- 11-digit product format
- 519910836
- Labeler code
- 51991
- Product ID
- 51991-836_ecbdaa43-06bf-4080-9a71-0f6c7def3ff4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Epinastine Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA090870
- Marketing category
- ANDA
- Marketing start
- 2013-11-05
- 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51991-836-75 | 51991083675 | 1 BOTTLE, DROPPER in 1 CARTON (51991-836-75) > 5 mL in 1 BOTTLE, DROPPER | 2013-11-05 | 0000-00-00 | No | No | Current |