OLOPATADINE HYDROCHLORIDE
- Product NDC
- 46122-671
- 11-digit product format
- 461220671
- Labeler code
- 46122
- Product ID
- 46122-671_1f56c080-a9b4-46ba-882b-3d3d92138ce6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OLOPATADINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Amerisource Bergen
- Application
- ANDA209995
- Marketing category
- ANDA
- Marketing start
- 2021-01-19
- Substance
- OLOPATADINE HYDROCHLORIDE
- Active strength
- 2 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OLOPATADINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLOPATADINE HYDROCHLORIDE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2XG66W44KF |
| Rxcui | 1111343 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46122-671-27 | OLOPATADINE HYDROCHLORIDE | 1 in 1 CARTON | SOLUTION | 1 | | 5 |
| 46122-671-27 | OLOPATADINE HYDROCHLORIDE | 2.5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 2.5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46122-671 | OLOPATADINE HYDROCHLORIDE SOLUTION [AMERISOURCE BERGEN] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230711_067baa0b-5c01-4908-92de-ad79c73d2c37.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 |
|---|
| 46122-671-27 | 46122067127 | 1 BOTTLE, PLASTIC in 1 CARTON (46122-671-27) / 2.5 mL in 1 BOTTLE, PLASTIC | 2021-01-19 | 0000-00-00 | No | No | Current |