OLOPATADINE HYDROCHLORIDE
- Product NDC
- 80539-001
- 11-digit product format
- 805390001
- Labeler code
- 80539
- Product ID
- 80539-001_12d48ef6-ccf1-4bc3-8469-0061bb083f7c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OLOPATADINE HYDROCHLORIDE
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Allwell Health Inc
- Application
- ANDA209995
- Marketing category
- ANDA
- Marketing start
- 2020-07-15
- Substance
- OLOPATADINE HYDROCHLORIDE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A209995-001 | OLOPATADINE HYDROCHLORIDE | OLOPATADINE HYDROCHLORIDE | EQ 0.2% BASE | SOLUTION/DROPS / OPHTHALMIC | | | 2019-04-04 |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings For external use only
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 |
|---|
| 80539-001-39 | OLOPATADINE HYDROCHLORIDE | 2.5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 2.5 | | 1 |
| 80539-001-39 | OLOPATADINE HYDROCHLORIDE | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80539-001 | OLOPATADINE HYDROCHLORIDE SOLUTION [ALLWELL HEALTH INC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210302_12d48ef6-ccf1-4bc3-8469-0061bb083f7c.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 |
|---|
| 80539-001-39 | 80539000139 | 1 BOTTLE, PLASTIC in 1 CARTON (80539-001-39) / 2.5 mL in 1 BOTTLE, PLASTIC | 2020-07-15 | 0000-00-00 | No | No | Current |