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NDC 00536-1253-91 Sodium Chloride Hypertonicity Ophthalmic 50 mg/g Details
Sodium Chloride Hypertonicity Ophthalmic 50 mg/g
Sodium Chloride Hypertonicity Ophthalmic is a OPHTHALMIC OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. The primary component is SODIUM CHLORIDE.
Product Information
| NDC | 00536-1253 |
|---|---|
| Product ID | 0536-1253_d67c8b34-5245-49ab-925d-dc95629156d9 |
| Associated GPIs | 86804030104205 |
| GCN Sequence Number | 007737 |
| GCN Sequence Number Description | sodium chloride OINT. (G) 5 % OPHTHALMIC |
| HIC3 | Q6A |
| HIC3 Description | OPHTHALMIC PREPARATIONS, MISCELLANEOUS |
| GCN | 31880 |
| HICL Sequence Number | 003389 |
| HICL Sequence Number Description | SODIUM CHLORIDE |
| Brand/Generic | Generic |
| Proprietary Name | Sodium Chloride Hypertonicity Ophthalmic |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sodium chloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | OINTMENT |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/g |
| Substance Name | SODIUM CHLORIDE |
| Labeler Name | Rugby Laboratories |
| Pharmaceutical Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part349 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00536-1253-91 (00536125391)
| NDC Package Code | 0536-1253-91 |
|---|---|
| Billing NDC | 00536125391 |
| Package | 1 TUBE in 1 CARTON (0536-1253-91) / 3.5 g in 1 TUBE |
| Marketing Start Date | 2020-11-06 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 2.89683 |
| Pricing Unit | GM |
| Effective Date | 2024-01-17 |
| NDC Description | SODIUM CHLORIDE 5% EYE OINT |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 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
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 7546770d-bc12-44b8-9fe0-fc3f5e1d12d1 Details
Warnings
For external use only
Do not use except under the advice and supervision of a doctor
When using this product
- •
- it may cause temporary burning and irritation
- •
- replace cap after use
- •
- to avoid contamination do not touch tip of container to any surface
Stop use and ask a doctor if
- •
- condition worsens or persists for more than 72 hours
- •
- you experience eye pain, changes in vision, continued redness or irritation of the eye
Keep Out of Reach of Children
Directions
Other information
- •
- store at 15° - 25°C (59° - 77°F)
- •
- keep tightly closed
- •
- DO NOT FREEZE
- •
- see crimp of tube or carton for Lot Number and Expiration Date
- •
- do not use if difficult to dispense or visible particles are seen in the product
- •
- serious side effects associated with use of the product may be reported to the phone number below
Package/Label Principal Display Panel Carton
INGREDIENTS AND APPEARANCE
| SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC
sodium chloride ointment |
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| Labeler - Rugby Laboratories (079246066) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Bausch & Lomb Incorporated | 079587625 | MANUFACTURE(0536-1253) | |
Revised: 11/2021
Document Id: d67c8b34-5245-49ab-925d-dc95629156d9
Set id: 7546770d-bc12-44b8-9fe0-fc3f5e1d12d1
Version: 2
Effective Time: 20211122