OLOPATADINE HYDROCHLORIDE
- Product NDC
- 69168-480
- 11-digit product format
- 691680480
- Labeler code
- 69168
- Product ID
- 69168-480_94283fa2-f59d-4cfd-9f02-e4aaf60382ca
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OLOPATADINE HYDROCHLORIDE
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Allegiant Health
- Application
- ANDA078350
- Marketing category
- ANDA
- Marketing start
- 2025-05-05
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2XG66W44KF | OLOPATADINE HYDROCHLORIDE | 140462-76-6 | OLOPATADINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69168-480-02 | 69168048002 | 2 BOTTLE in 1 CARTON (69168-480-02) / 5 mL in 1 BOTTLE | 2 bottle | 2025-07-31 | No | No | Historical |
| 69168-480-65 | 69168048065 | 1 BOTTLE in 1 CARTON (69168-480-65) / 5 mL in 1 BOTTLE | 1 bottle | 2025-05-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| 480 - Eye Relief | Allegiant Health | 2025-05-05 | HUMAN OTC DRUG LABEL | 2 |