Over-the-counter drug · OTC MONOGRAPH DRUG
Oftal-Mycin Lubricant Ophthalmic (Light mineral, white petrolatum) NDC 48201-301
White petrolatum 83 g/100g; Light mineral oil 15 g/100g · Ointment · Ophthalmic · GRANDALL DISTRIBUTING, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 48201-301-11 | 4820103011148201030111 | 3.5 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
N448201030111followed by a unit qualifier and the quantityPackage 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.
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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