OLOPATADINE HYDROCHLORIDE
- Product NDC
- 76162-020
- 11-digit product format
- 761620020
- Labeler code
- 76162
- Product ID
- 76162-020_a413aedd-c114-40a3-bfad-1f9db0565b0f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OLOPATADINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- TOPCO ASSOCIATES LLC
- Application
- ANDA204812
- Marketing category
- ANDA
- Marketing start
- 2020-07-15
- 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
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 |
|---|
| 76162-020-40 | 76162002040 | 1 BOTTLE, PLASTIC in 1 CARTON (76162-020-40) / 5 mL in 1 BOTTLE, PLASTIC | 2020-07-15 | No | No | Historical |