Olopatadine Hydrochloride Ophthalmic Solution
- Product NDC
- 55910-137
- 11-digit product format
- 559100137
- Labeler code
- 55910
- Product ID
- 55910-137_47607abb-5d8a-d789-ee04-1879d00b1897
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Olopatadine Hydrochloride Ophthalmic
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- DOLGENCORP, LLC
- Application
- ANDA209752
- Marketing category
- ANDA
- Marketing start
- 2021-12-01
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Olopatadine Hydrochloride Ophthalmic Solution
- Brand name suffix
- Once Daily
- Listing expiration
- 2026-12-31
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 |
|---|
| 55910-137-25 | Olopatadine Hydrochloride Ophthalmic Solution Once Daily | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 55910-137-25 | Olopatadine Hydrochloride Ophthalmic Solution Once Daily | 2.5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 2.5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55910-137 | OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION ONCE DAILY (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION [DOLGENCORP, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20231019_fa75f236-0170-e7be-ce8c-7dff7c36fac8.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 |
|---|
| 55910-137-25 | 55910013725 | 1 BOTTLE, PLASTIC in 1 CARTON (55910-137-25) / 2.5 mL in 1 BOTTLE, PLASTIC | 2021-12-01 | 0000-00-00 | No | No | Current |