Olopatadine hydrochloride
- Product NDC
- 60505-6221
- 11-digit product format
- 605056221
- Labeler code
- 60505
- Product ID
- 60505-6221_ac44fb6f-d383-37f2-9416-6d249604140e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Olopatadine hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Apotex Corp.
- Application
- ANDA078350
- Marketing category
- ANDA
- Marketing start
- 2022-10-06
- Substance
- OLOPATADINE HYDROCHLORIDE
- Active strength
- 1 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 | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2XG66W44KF |
| Rxcui | 1111339 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-6221-0 | Olopatadine hydrochloride | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 5 | | 4 |
| 60505-6221-0 | Olopatadine hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-6221 | OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS [APOTEX CORP.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240929_cc178825-1a4e-6bca-a00d-aa28d5abe589.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 |
|---|
| 60505-6221-0 | 60505622100 | 1 BOTTLE, PLASTIC in 1 CARTON (60505-6221-0) / 5 mL in 1 BOTTLE, PLASTIC | 2022-10-06 | 0000-00-00 | No | No | Current |