NDC codes

FDA NDC Directory
Product NDC (as listed)48201-301Labeler and product segments. Claims need a package NDC.
Product NDC at billing width48201-0301Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
48201-301-1148201030111482010301113.5 g in 1 BOTTLE (48201-301-11)Marketed from Dec 18, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Oftal-Mycin Lubricant Ophthalmic
Generic name (nonproprietary)
light mineral, white petrolatum
Active ingredients
White petrolatum — 83 g/100gLight mineral oil — 15 g/100g
Dosage form
Ointment
Route
Ophthalmic
Labeler
GRANDALL DISTRIBUTING, LLCNDC labeler code 48201
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 014
Marketing start
Listing expires
Identifiers
Product ID 48201-301_422c0915-37ab-dfd4-e063-6294a90ac5d3SPL ID 422c0915-37ab-dfd4-e063-6294a90ac5d3SPL set ID 298db04a-21a9-e46e-e063-6294a90acee2RxCUI 746083UNII B6E5W8RQJ4, N6K5787QVP

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N448201030111 followed by a unit qualifier and the quantity

Package 48201-0301-11. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

USES for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun may be used as a protectant against further irritation

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 48201-301

What is NDC 48201-301?
48201-301 is the product NDC for Oftal-Mycin Lubricant Ophthalmic, White petrolatum 83 g/100g; Light mineral oil 15 g/100g ointment, listed with the FDA by GRANDALL DISTRIBUTING, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Oftal-Mycin Lubricant Ophthalmic (Light mineral, White petrolatum).
What is the active ingredient?
White petrolatum, Light mineral oil.
Who is the labeler?
GRANDALL DISTRIBUTING, LLC, NDC labeler code 48201. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Oftal-Mycin Lubricant Ophthalmic?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 014

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

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