OLOPATADINE HYDROCHLORIDE
- Product NDC
- 58602-013
- 11-digit product format
- 586020013
- Labeler code
- 58602
- Product ID
- 58602-013_223ca879-71fd-4a04-94d1-ae8aae206948
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OLOPATADINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Aurohealth LLC
- Application
- ANDA209995
- Marketing category
- ANDA
- Marketing start
- 2020-07-15
- Substance
- OLOPATADINE HYDROCHLORIDE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- 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
- OLOPATADINE HYDROCHLORIDE
- 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 |
|---|
| 58602-013-39 | OLOPATADINE HYDROCHLORIDE | 2.5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 2.5 | | 3 |
| 58602-013-39 | OLOPATADINE HYDROCHLORIDE | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 58602-013-41 | OLOPATADINE HYDROCHLORIDE | 2 in 1 CARTON | SOLUTION | 2 | | 3 |
| 58602-013-41 | OLOPATADINE HYDROCHLORIDE | 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 |
|---|
| 58602-013 | OLOPATADINE HYDROCHLORIDE SOLUTION [AUROHEALTH LLC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20201010_5f9e93e7-ff12-484d-add8-4f834193c1c6.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 |
|---|
| 58602-013-39 | 58602001339 | 1 BOTTLE, PLASTIC in 1 CARTON (58602-013-39) / 2.5 mL in 1 BOTTLE, PLASTIC | 2020-07-15 | 0000-00-00 | No | No | Current |
| 58602-013-41 | 58602001341 | 2 BOTTLE, PLASTIC in 1 CARTON (58602-013-41) / 2.5 mL in 1 BOTTLE, PLASTIC | 2020-07-15 | 0000-00-00 | No | No | Current |