olopatadine hydrochloride
- Product NDC
- 45802-104
- 11-digit product format
- 458020104
- Labeler code
- 45802
- Product ID
- 45802-104_dca15bfb-d84a-46e3-800c-3e3e1eaa6967
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olopatadine Hydrochloride
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA202853
- Marketing category
- ANDA
- Marketing start
- 2017-06-14
- Substance
- OLOPATADINE HYDROCHLORIDE
- Active strength
- 665 ug/1
- 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 | 665 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2XG66W44KF |
| Rxcui | 1797895 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-104-01 | olopatadine hydrochloride | 1 in 1 CARTON | SPRAY | 1 | | 10 |
| 45802-104-01 | olopatadine hydrochloride | 240 in 1 BOTTLE | SPRAY | 240 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-104 | OLOPATADINE HYDROCHLORIDE SPRAY [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240308_126ff6eb-62ae-46f2-ab1e-7ac19346c36b.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 |
|---|
| 45802-104-01 | 45802010401 | 1 BOTTLE in 1 CARTON (45802-104-01) / 240 SPRAY in 1 BOTTLE | 1 bottle | 2017-06-14 | 0000-00-00 | No | No | Current |