Eye Allergy Itch Relief
- Product NDC
- 70000-0053
- 11-digit product format
- 700000053
- Labeler code
- 70000
- Product ID
- 70000-0053_ece56087-7def-0eb9-13d3-b187763b7f7b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Olopatadine HCl
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- CARDINAL HEALTH 110, LLC. DBA LEADER
- Application
- ANDA209752
- Marketing category
- ANDA
- Marketing start
- 2021-01-15
- Substance
- OLOPATADINE HYDROCHLORIDE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eye Allergy Itch Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLOPATADINE HYDROCHLORIDE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2XG66W44KF |
| Rxcui | 1111343 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70000-0053-1 | Eye Allergy Itch Relief | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 8 |
| 70000-0053-1 | Eye Allergy Itch Relief | 2.5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2.5 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0053 | EYE ALLERGY ITCH RELIEF (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION [LEADER/ CARDINAL HEALTH 110, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20231019_135bb2de-b2c0-6f0c-6204-3acbb48dcfbd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70000-0053-1 | 70000005301 | 1 BOTTLE, DROPPER in 1 CARTON (70000-0053-1) / 2.5 mL in 1 BOTTLE, DROPPER | 2021-01-15 | 0000-00-00 | No | No | Current |