Olopatadine Hydrochloride Ophthalmic Solution
- Product NDC
- 68083-398
- 11-digit product format
- 680830398
- Labeler code
- 68083
- Product ID
- 68083-398_e05ea1df-8db8-4261-be59-8f303da3b57e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- olopatadine hydrochloride ophthalmic
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Gland Pharma Limited
- Application
- ANDA213514
- Marketing category
- ANDA
- Marketing start
- 2026-01-06
- 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-398-01 | Olopatadine Hydrochloride Ophthalmic Solution | 2.5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 2.5 | | 2 |
| 68083-398-01 | Olopatadine Hydrochloride Ophthalmic Solution | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 68083-398-85 | olopatadine hydrochloride ophthalmic solution | 1000 in 1 CASE | SOLUTION | 1000 | | 1 |
| 68083-398-85 | olopatadine hydrochloride ophthalmic solution | 2.5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 2.5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-398-01 | 68083039801 | 1 BOTTLE, PLASTIC in 1 CARTON (68083-398-01) / 2.5 mL in 1 BOTTLE, PLASTIC | 2026-01-06 | No | No | Historical |
| 68083-398-85 | 68083039885 | 1000 in 1 CASE | | | | Historical |