Olopatadine Hydrochloride
- Product NDC
- 62332-709
- 11-digit product format
- 623320709
- Labeler code
- 62332
- Product ID
- 62332-709_4c96f15a-cc39-4533-a7b3-cbc018e2046e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- olopatadine hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA209919
- Marketing category
- ANDA
- Marketing start
- 2021-02-18
- 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
- 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 | 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 |
|---|
| 62332-709-05 | Olopatadine Hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 5 |
| 62332-709-05 | Olopatadine Hydrochloride | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-709 | OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241219_bd1f9779-d048-46ff-a570-ce3ad92715e7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62332-709-05 | 62332070905 | 1 BOTTLE in 1 CARTON (62332-709-05) / 5 mL in 1 BOTTLE | 1 bottle | 2021-02-18 | 0000-00-00 | No | No | Current |