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NDC 17478-0308-05 Olopatadine 1 mg/mL Details
Olopatadine 1 mg/mL
Olopatadine is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Akorn. 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: 17478-0308-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Olopatadine Ophthalmic
Product Information
| NDC | 17478-0308 |
|---|---|
| Product ID | 17478-308_bd344833-8428-4e3c-9297-6d27729d3489 |
| 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 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Olopatadine Hydrochloride |
| 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 | Akorn |
| 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 | ANDA204532 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 17478-0308-05 (17478030805)
| NDC Package Code | 17478-308-05 |
|---|---|
| Billing NDC | 17478030805 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (17478-308-05) / 5 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 2021-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1.21911 |
| Pricing Unit | ML |
| Effective Date | 2022-11-23 |
| 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 | 2022-11-23 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL e513d024-f121-495e-9957-f2e1da272a48 Details
Warnings
For external use only
Do not use
- if solution changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
- to treat contact lens related irritation
When using the product
- do not touch tip of container to any surface to avoid contamination
- remove contact lenses before use
- wait at least 10 minutes before reinserting contact lenses after use
- do not wear a contact lens if your eye is red
Directions
-
adults and children 2 years of age and older:
- put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day
- if using other ophthalmic products while using this product, wait at least 5 minutes between each product
- replace cap after each use
- children under 2 years of age: consult a doctor
Inactive ingredients
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Carton Label:
Original NDC 17478-308-05
Prescription
Strength Akorn logo
Olopatadine
HCl Ophthalmic
Solution, USP
0.1%
Antihistamine and Redness Reliever
Eye Allergy Itch & Redness Relief
Works in Minutes
Relief from Allergens:
• Pet Dander
• Pollen
• Grass
• Ragweed
TWICE DAILY
STERILE
5 mL (0.17 FL OZ)
INGREDIENTS AND APPEARANCE
| OLOPATADINE
olopatadine hydrochloride solution/ drops |
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| Labeler - Akorn (117696770) |
| Registrant - AKORN OPERATING COMPANY LLC (117693100) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696840 | LABEL(17478-308) , MANUFACTURE(17478-308) , PACK(17478-308) , ANALYSIS(17478-308) , STERILIZE(17478-308) | |
Revised: 2/2022
Document Id: bd344833-8428-4e3c-9297-6d27729d3489
Set id: e513d024-f121-495e-9957-f2e1da272a48
Version: 2
Effective Time: 20220203