Olopatadine Hydrochloride Ophthalmic Solution
- Product NDC
- 75907-285
- 11-digit product format
- 759070285
- Labeler code
- 75907
- Product ID
- 75907-285_32d8bd94-1b82-6ec2-53ad-9de2c4c26ea5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- olopatadine hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA213514
- Marketing category
- ANDA
- Marketing start
- 2026-04-15
- Substance
- OLOPATADINE HYDROCHLORIDE
- Active strength
- 7 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 Hydrochloride Ophthalmic Solution
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLOPATADINE HYDROCHLORIDE | 7 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2XG66W44KF |
| Rxcui | 1601086 |
DailyMed Product Concepts#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 75907-285-02 | 75907028502 | 1 BOTTLE, DROPPER in 1 CARTON (75907-285-02) / 2.5 mL in 1 BOTTLE, DROPPER | 2026-04-15 | No | No | Current |
| 75907-285-10 | 75907028510 | 1000 BOTTLE, DROPPER in 1 CASE (75907-285-10) / 2.5 mL in 1 BOTTLE, DROPPER | 02-FEB-26 | | | Current |
| 75907-285-25 | 75907028525 | 2 BOTTLE, DROPPER in 1 CARTON (75907-285-25) / 2.5 mL in 1 BOTTLE, DROPPER | 2026-04-15 | No | No | Current |