NDC Package 48201-301-11 Oftal-mycin Lubricant Ophthalmic

Light Mineral,White Petrolatum Ointment Ophthalmic - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
48201-301-11
Package Description:
3.5 g in 1 BOTTLE
Product Code:
Proprietary Name:
Oftal-mycin Lubricant Ophthalmic
Non-Proprietary Name:
Light Mineral, White Petrolatum
Substance Name:
Light Mineral Oil; White Petrolatum
Usage Information:
For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sunmay be used as a protectant against further irritation
11-Digit NDC Billing Format:
48201030111
NDC to RxNorm Crosswalk:
  • RxCUI: 746083 - mineral oil 15 % / petrolatum 83 % Ophthalmic Ointment
  • RxCUI: 746083 - mineral oil 0.15 MG/MG / petrolatum 0.83 MG/MG Ophthalmic Ointment
  • RxCUI: 746083 - mineral oil 15 % / petrolatum, white 83 % Ophthalmic Ointment
Product Type:
Human Otc Drug
Labeler Name:
Grandall Distributing, Llc
Dosage Form:
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s):
Ophthalmic - Administration to the external eye.
Sample Package:
No
FDA Application Number:
M014
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
12-18-2024
Listing Expiration Date:
12-31-2026
Exclude Flag:
N

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 NDC 48201-301-11?

The NDC Packaged Code 48201-301-11 is assigned to a package of 3.5 g in 1 bottle of Oftal-mycin Lubricant Ophthalmic, a human over the counter drug labeled by Grandall Distributing, Llc. The product's dosage form is ointment and is administered via ophthalmic form.

Is NDC 48201-301 included in the NDC Directory?

Yes, Oftal-mycin Lubricant Ophthalmic with product code 48201-301 is active and included in the NDC Directory. The product was first marketed by Grandall Distributing, Llc on December 18, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 48201-301-11?

The 11-digit format is 48201030111. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-248201-301-115-4-248201-0301-11