Olopatadine Hydrochloride
- Product NDC
- 61314-320
- 11-digit product format
- 613140320
- Labeler code
- 61314
- Product ID
- 61314-320_0f71b717-d3f6-4b3b-87d2-60327ea5831f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- olopatadine hydrochloride
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- Sandoz Inc
- Application
- NDA021861
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2015-04-01
- Marketing end
- 0000-00-00
- Substance
- OLOPATADINE HYDROCHLORIDE
- Active strength
- 665 ug/100uL
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OLOPATADINE HYDROCHLORIDE | ACTIVE INGREDIENT | 2XG66W44KF | OLOPATADINE HYDROCHLORIDE SPRAY, METERED [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| OLOPATADINE | ACTIVE MOIETY | D27V6190PM | OLOPATADINE HYDROCHLORIDE SPRAY, METERED [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | OLOPATADINE HYDROCHLORIDE SPRAY, METERED [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | OLOPATADINE HYDROCHLORIDE SPRAY, METERED [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | OLOPATADINE HYDROCHLORIDE SPRAY, METERED [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | OLOPATADINE HYDROCHLORIDE SPRAY, METERED [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | OLOPATADINE HYDROCHLORIDE SPRAY, METERED [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | OLOPATADINE HYDROCHLORIDE SPRAY, METERED [FALCON PHARMACEUTICALS, LTD.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OLOPATADINE HYDROCHLORIDE SPRAY, METERED [FALCON PHARMACEUTICALS, LTD.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61314-320 | OLOPATADINE HYDROCHLORIDE SPRAY, METERED [SANDOZ INC] | 6 | Legacy NDC | 20221217_6393e997-7080-4ce6-8a34-2f80b48f5a3a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61314-320-01 | 61314032001 | 1 BOTTLE in 1 CARTON (61314-320-01) > 30500 uL in 1 BOTTLE | 1 bottle | 2015-04-01 | 0000-00-00 | No | No | Current |