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NDC 17478-0623-12 Sodium Chloride 50 mg/mL Details
Sodium Chloride 50 mg/mL
Sodium Chloride is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Akorn. The primary component is SODIUM CHLORIDE.
Product Information
| NDC | 17478-0623 |
|---|---|
| Product ID | 17478-623_01a8dedc-8c60-4060-a49b-70f8d53db07d |
| Associated GPIs | 86804030102005 |
| GCN Sequence Number | 007739 |
| GCN Sequence Number Description | sodium chloride DROPS 5 % OPHTHALMIC |
| HIC3 | Q6A |
| HIC3 Description | OPHTHALMIC PREPARATIONS, MISCELLANEOUS |
| GCN | 31923 |
| HICL Sequence Number | 003389 |
| HICL Sequence Number Description | SODIUM CHLORIDE |
| Brand/Generic | Generic |
| Proprietary Name | Sodium Chloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sodium Chloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION/ DROPS |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | SODIUM CHLORIDE |
| Labeler Name | Akorn |
| 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 | 2023-12-31 |
Package
Package Images
NDC 17478-0623-12 (17478062312)
| NDC Package Code | 17478-623-12 |
|---|---|
| Billing NDC | 17478062312 |
| Package | 1 BOTTLE, DROPPER in 1 CARTON (17478-623-12) / 15 mL in 1 BOTTLE, DROPPER |
| Marketing Start Date | 1998-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.51898 |
| Pricing Unit | ML |
| Effective Date | 2022-11-23 |
| NDC Description | SODIUM CHLORIDE 5% EYE DROP |
| 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 ab12c419-4b1a-4119-9e23-76ce7a89d1a7 Details
Warnings
Do not use
- this product except under the advice and supervision of a doctor.
- if imprinted seal is broken or missing.
- if solution changes color or becomes cloudy.
When using this product
- temporary burning and irritation upon being instilled into eye may occur.
- to avoid contamination, do not touch tip of container to any surface
- replace cap after each use
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| SODIUM CHLORIDE
sodium chloride solution/ drops |
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| Labeler - Akorn (117693100) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696790 | LABEL(17478-623) , PACK(17478-623) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696832 | MANUFACTURE(17478-623) , ANALYSIS(17478-623) , STERILIZE(17478-623) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696840 | ANALYSIS(17478-623) , LABEL(17478-623) , MANUFACTURE(17478-623) , PACK(17478-623) , STERILIZE(17478-623) | |
Revised: 7/2022
Document Id: 01a8dedc-8c60-4060-a49b-70f8d53db07d
Set id: ab12c419-4b1a-4119-9e23-76ce7a89d1a7
Version: 8
Effective Time: 20220701