Olopatadine hydrochloride
- Product NDC
- 60505-6222
- 11-digit product format
- 605056222
- Labeler code
- 60505
- Product ID
- 60505-6222_d84abde6-ee13-fe9c-b477-f7965453aa2d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Olopatadine hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Apotex Corp.
- Application
- ANDA090918
- Marketing category
- ANDA
- Marketing start
- 2022-10-06
- 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
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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 60505-6222-2 | 60505622202 | 1 BOTTLE, PLASTIC in 1 CARTON (60505-6222-2) / 2.5 mL in 1 BOTTLE, PLASTIC (60505-6222-1) | 2022-10-06 | No | No | Historical |
| 60505-6222-3 | 60505622203 | 2 BOTTLE, PLASTIC in 1 CARTON (60505-6222-3) / 2.5 mL in 1 BOTTLE, PLASTIC | 2022-10-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Drug Facts | Apotex Corp. | 2025-09-19 | HUMAN OTC DRUG LABEL | 4 |