Leader Olopatadine Hydrochloride Ophthalmic Solution
- Product NDC
- 70000-0717
- 11-digit product format
- 700000717
- Labeler code
- 70000
- Product ID
- 70000-0717_32bff197-0006-d853-e063-6394a90a8cc2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Olopatadine Hydrochloride Ophthalmic Solution
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- CARDINAL HEALTH
- Application
- ANDA206046
- Marketing category
- ANDA
- Marketing start
- 2025-04-15
- Substance
- OLOPATADINE HYDROCHLORIDE
- Active strength
- 1 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Leader Olopatadine Hydrochloride Ophthalmic Solution
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLOPATADINE HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2XG66W44KF |
| Rxcui | 1111339 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70000-0717-1 | Leader Olopatadine Hydrochloride Ophthalmic Solution | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 70000-0717-1 | Leader Olopatadine Hydrochloride Ophthalmic Solution | 5 mL in 1 BOTTLE | SOLUTION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0717 | LEADER OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION) SOLUTION [CARDINAL HEALTH] | 2 | Current NDC, 2 package rows | 20250416_d91a3512-b87b-4950-b41d-8d094c0e2c38.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70000-0717-1 | 70000071701 | 1 BOTTLE in 1 CARTON (70000-0717-1) / 5 mL in 1 BOTTLE | 1 bottle | 2025-04-15 | No | No | Historical |