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NDC 00536-1308-40 Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL Details
Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL
Olopatadine Hydrochloride Ophthalmic Solution is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. The primary component is OLOPATADINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Prescription ophthalmic olopatadine (Pazeo) and nonprescription ophthalmic olopatadine (Pataday) are used to relieve itchy eyes caused by allergic reactions to pollen, ragweed, grass, animal hair, or pet dander. Olopatadine is in a class of medications called mast cell stabilizers. It works by preventing the release of substances that cause eye itching.
Related Packages: 00536-1308-40Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Olopatadine Ophthalmic
Product Information
| NDC | 00536-1308 |
|---|---|
| Product ID | 0536-1308_2634b4fc-71ba-e5db-76ad-6ebdc52ae2d3 |
| Associated GPIs | 86802065102020 |
| GCN Sequence Number | 030796 |
| GCN Sequence Number Description | olopatadine HCl DROPS 0.1 % OPHTHALMIC |
| HIC3 | Q6R |
| HIC3 Description | EYE ANTIHISTAMINES |
| GCN | 68321 |
| HICL Sequence Number | 012815 |
| HICL Sequence Number Description | OLOPATADINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Olopatadine Hydrochloride Ophthalmic Solution |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Olopatadine Hydrochloride Ophthalmic |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/mL |
| Substance Name | OLOPATADINE HYDROCHLORIDE |
| Labeler Name | Rugby Laboratories |
| Pharmaceutical Class | Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209619 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00536-1308-40 (00536130840)
| NDC Package Code | 0536-1308-40 |
|---|---|
| Billing NDC | 00536130840 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (0536-1308-40) / 5 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2021-01-05 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1.52638 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | OLOPATADINE HCL 0.1% EYE DROPS |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
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