Olopatadine
- Product NDC
- 50090-7959
- 11-digit product format
- 500907959
- Labeler code
- 50090
- Product ID
- 50090-7959_edfacea9-790d-4adc-8cc4-fed868dc2cc7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Olopatadine
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- A-S Medication Solutions
- Application
- ANDA206306
- Marketing category
- ANDA
- Marketing start
- 2024-04-15
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Olopatadine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLOPATADINE HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2XG66W44KF |
| Rxcui | 1111339 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7959-0 | Olopatadine | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 5 | | 1 |
| 50090-7959-0 | Olopatadine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7959-0 | 50090795900 | 1 BOTTLE, PLASTIC in 1 CARTON (50090-7959-0) / 5 mL in 1 BOTTLE, PLASTIC | 2026-05-05 | No | No | Historical |