Olopatadine Hcl Solution/ Drops
NDC Package 70512-520-05
Package Information
Olopatadine Hcl solution/ dropses is a medication an antihistamine used to treat itching and redness in the eyes due to allergies. This formulation utilizes a solution/ drops delivery system. Marketed by Sola Pharmaceuticals, this product is identified by NDC 70512-520 and is authorized under FDA application ANDA203152.
Identification & Billing
- RxCUI: 1111339 - olopatadine HCl 0.1 % Ophthalmic Solution
- RxCUI: 1111339 - olopatadine 1 MG/ML Ophthalmic Solution
- RxCUI: 1111339 - olopatadine 0.1 % Ophthalmic Solution
- RxCUI: 1111339 - olopatadine 1 MG/ML (as olopatadine HCl 1.11 MG/ML) Ophthalmic Solution
Clinical Specifications
- Decreased Histamine Release - [PE] (Physiologic Effect)
- Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
- Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Histamine-1 Receptor Inhibitor - [EPC] (Established Pharmacologic Class)
- Mast Cell Stabilizer - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 70512 - Sola Pharmaceuticals
- 70512-520 - Olopatadine Hcl
- 70512-520-05 - 1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC
- 70512-520 - Olopatadine Hcl
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 70512-520-05 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 5 ml in 1 bottle, plastic of Olopatadine Hcl, a human over the counter drug labeled by Sola Pharmaceuticals. This solution/ drops is formulated for ophthalmic use and contains olopatadine hydrochloride as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sola Pharmaceuticals on July 05, 2022. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
This medication is an antihistamine used to treat itching and redness in the eyes due to allergies. This medication is not recommended for the treatment of eye irritation due to wearing contact lenses.
How is this Sola Pharmaceuticals product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 70512052005. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.