Olopatadine Hydrochloride Ophthalmic Solution
- Product NDC
- 68083-477
- 11-digit product format
- 680830477
- Labeler code
- 68083
- Product ID
- 68083-477_c1481a14-8fce-4e29-b393-3b514bda4ef7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Olopatadine Hydrochloride Ophthalmic
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Gland Pharma Limited
- Application
- ANDA209619
- Marketing category
- ANDA
- Marketing start
- 2017-02-14
- 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 Hydrochloride Ophthalmic Solution
- 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 |
|---|
| 68083-477-01 | Olopatadine Hydrochloride Ophthalmic Solution | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 5 | | 2 |
| 68083-477-01 | Olopatadine Hydrochloride Ophthalmic Solution | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-477 | OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION/ DROPS [GLAND PHARMA LIMITED] | 1 | Current NDC, Legacy NDC, 2 package rows | 20200819_e7907389-32be-4d83-a6e6-4360842d4893.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-477-01 | 68083047701 | 1 BOTTLE, PLASTIC in 1 CARTON (68083-477-01) / 5 mL in 1 BOTTLE, PLASTIC | 2017-02-14 | 0000-00-00 | No | No | Current |