Olopatadine Hydrochloride
- Product NDC
- 62332-710
- 11-digit product format
- 623320710
- Labeler code
- 62332
- Product ID
- 62332-710_b2029f57-947f-4e34-a1f4-d6a4e7d89046
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- olopatadine hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA209420
- Marketing category
- ANDA
- Marketing start
- 2021-01-25
- 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 |
|---|
| 62332-710-03 | Olopatadine Hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 2 |
| 62332-710-03 | Olopatadine Hydrochloride | 2.5 mL in 1 BOTTLE | SOLUTION/ DROPS | 2.5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-710 | OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241011_75823e5d-562a-43c2-8365-6f3f9484c9bf.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 |
|---|
| 62332-710-03 | 62332071003 | 1 BOTTLE in 1 CARTON (62332-710-03) / 2.5 mL in 1 BOTTLE | 1 bottle | 2021-01-25 | 0000-00-00 | No | No | Current |