EPINASTINE HYDROCHLORIDE
- Product NDC
- 70069-008
- 11-digit product format
- 700690008
- Labeler code
- 70069
- Product ID
- 70069-008_a873a505-bb9c-4430-8921-8d800df991c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- EPINASTINE HYDROCHLORIDE
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Somerset Therapeutics, LLC
- Application
- ANDA090951
- Marketing category
- ANDA
- Marketing start
- 2016-09-14
- Substance
- EPINASTINE HYDROCHLORIDE
- Active strength
- .5 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- EPINASTINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EPINASTINE HYDROCHLORIDE | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GFM415S5XL |
| Rxcui | 860654 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70069-008-01 | EPINASTINE HYDROCHLORIDE | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 7 |
| 70069-008-01 | EPINASTINE HYDROCHLORIDE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-008 | EPINASTINE HYDROCHLORIDE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250326_0d4ee45c-e58f-4b7c-b389-898f5c27f54d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70069-008-01 | 70069000801 | 1 BOTTLE in 1 CARTON (70069-008-01) / 5 mL in 1 BOTTLE | 1 bottle | 2016-09-14 | | No | No | Historical |
| 70069-008-10 | 70069000810 | 10 CARTON in 1 CARTON (70069-008-10) > 1 BOTTLE in 1 CARTON (70069-008-01) > 5 mL in 1 BOTTLE | 10 carton | 2016-09-14 | 0000-00-00 | No | No | Current |