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NDC 69097-0600-33 Olopatadine Hydrochloride 2 mg/mL Details
Olopatadine Hydrochloride 2 mg/mL
Olopatadine Hydrochloride is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Cipla USA Inc.. 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: 69097-0600-33Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Olopatadine Ophthalmic
Product Information
| NDC | 69097-0600 |
|---|---|
| Product ID | 69097-600_8ab00345-d0c7-4f29-9990-b23c67657888 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Olopatadine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Olopatadine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 2 |
| Active Ingredient Units | mg/mL |
| Substance Name | OLOPATADINE HYDROCHLORIDE |
| Labeler Name | Cipla USA Inc. |
| Pharmaceutical Class | Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206087 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 69097-0600-33 (69097060033)
| NDC Package Code | 69097-600-33 |
|---|---|
| Billing NDC | 69097060033 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (69097-600-33) / 2.5 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2021-03-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 172dbf94-d618-42fe-9cb8-552e0e0625f2 Details
INDICATIONS AND USAGE
DO NOT USE
When using this product
Stop Use
KEEP OUT OF REACH OF CHILDREN
DIRECTION
● adults and children 2 years of age and older:
o put 1 drop in the affected eye(s) once daily, no more than once per day
o if using other ophthalmic products while using this product, wait at least 5 minutes between each product
o replace cap after each use
● children under 2 years of age: consult a doctor
INACTIVE INGREDIENT
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Strength
NDC 69097-600-33
Olopatadine
Hydrochloride
Ophthalmic
Solution, USP 0.2%
Antihistamine
ONCE DAILY
Eye allergy itch relief
Works in Minutes
Relief from Allergens:
● Pet Dander
● Pollen
● Grass
●Ragweed
Cipla
STERILE
2.5 mL (0.085 FL OZ)
Olopatadine
Hydrochloride
Ophthalmic Solution,
USP, 0.2%
Once Daily
Antihistamine
Eye Allergy Itch Relief
Sterile 2.5 mL (0.085 FL OZ)
INGREDIENTS AND APPEARANCE
| OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride solution/ drops |
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| Labeler - Cipla USA Inc. (078719707) |
| Registrant - Cipla USA Inc. (078719707) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Cipla Ltd. Indore | 918596409 | ANALYSIS(69097-600) , MANUFACTURE(69097-600) , LABEL(69097-600) , PACK(69097-600) | |