EPINASTINE HYDROCHLORIDE
- Product NDC
- 62756-329
- 11-digit product format
- 627560329
- Labeler code
- 62756
- Product ID
- 62756-329_28c115e2-5923-4870-8a0b-feef3d7ef6ab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- EPINASTINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA091626
- Marketing category
- ANDA
- Marketing start
- 2011-11-01
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62756-329-90 | EPINASTINE HYDROCHLORIDE | 5 mL in 1 BOTTLE | SOLUTION | 5 | | 5 |
| 62756-329-90 | EPINASTINE HYDROCHLORIDE | 1 in 1 CARTON | SOLUTION | 1 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62756-329 | EPINASTINE HYDROCHLORIDE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 5 | Legacy NDC, 2 package rows | 20181024_cafe4650-6aa4-4466-9beb-064ee5a0e401.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 62756-329-90 | 62756032990 | 5 mL in 1 BOTTLE | 5 ml | Historical |