OLOPATADINE HYDROCHLORIDE
- Product NDC
- 68001-530
- 11-digit product format
- 680010530
- Labeler code
- 68001
- Product ID
- 68001-530_dbd299b7-11c8-bf59-e053-2a95a90a2cd4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OLOPATADINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- BluePoint Laboratories
- Application
- ANDA209995
- Marketing category
- ANDA
- Marketing start
- 2022-04-08
- 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 |
|---|
| 68001-530-69 | OLOPATADINE HYDROCHLORIDE | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 68001-530-69 | OLOPATADINE HYDROCHLORIDE | 2.5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 2.5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-530 | OLOPATADINE HYDROCHLORIDE SOLUTION [BLUEPOINT LABORATORIES] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220408_dbd28ee2-bbb5-a4b1-e053-2a95a90afff4.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 |
|---|
| 68001-530-69 | 68001053069 | 1 BOTTLE, PLASTIC in 1 CARTON (68001-530-69) / 2.5 mL in 1 BOTTLE, PLASTIC | 2022-04-08 | 0000-00-00 | No | No | Current |