NDC codes

FDA NDC Directory
Product NDC (as listed)54312-019Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54312-0019Add 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
54312-019-3154312001931543120019311 TUBE in 1 CARTON (54312-019-31) / 28 g in 1 TUBEMarketed from Jul 30, 2016
54312-019-3554312001935543120019351 TUBE in 1 CARTON (54312-019-35) / 14 g in 1 TUBEMarketed from Jul 30, 2016

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

Generic name (nonproprietary)
neomycin sulfate
Active ingredients
Neomycin sulfate — 3.5 mg/g
Dosage form
Ointment
Route
Topical
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 004
Marketing start
Listing expires
Other FDA classes
Aminoglycosides (Chemical structure)
Identifiers
Product ID 54312-019_43fa588f-3f99-7492-e063-6294a90a5954SPL ID 43fa588f-3f99-7492-e063-6294a90a5954SPL set ID ba7a3331-466e-496f-bebd-9ee7067bcdb2RxCUI 1544556UNII 057Y626693UPC 0348875019315, 0348875019353
Pharmacologic class
Aminoglycoside Antibacterial

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N454312001931 followed by a unit qualifier and the quantity

Package 54312-0019-31. 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 First aid to help prevent infection in minor cuts, scrapes, and burns.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54312-019

What is NDC 54312-019?
54312-019 is the product NDC for Vitacilina Neomycin Sulfate First Aid Antibiotic, Neomycin sulfate 3.5 mg/g ointment, listed with the FDA by Compania Internacional de Comercio, S.A.P.I de C.V.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Vitacilina Neomycin Sulfate First Aid Antibiotic (Neomycin sulfate).
What is the active ingredient?
Neomycin sulfate.
Who is the labeler?
Compania Internacional de Comercio, S.A.P.I de C.V., NDC labeler code 54312. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Vitacilina Neomycin Sulfate First Aid Antibiotic?
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 004

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

FDA NDC Directory listings under M 004
ProductStrengthForm · routeLabelerProduct NDC
A-Cute Derm Antisepationbenzethonium chlorideBenzethonium chloride 2 mg/mLGelCutaneousABBE Laboratories, Inc.68605-7171
A-Cute Derm B-Kleerbenzethonium chlorideBenzethonium chloride 2 mg/mLGelCutaneousABBE Laboratories, Inc.68605-1040
Aerosoothetriple antibiotic ointmentBacitracin zinc 400 [iU]/g + 2 more ingredientsOintmentTopicalAero Healthcare US LLC55305-123
Alcare Extra Hand SanitizeralcoholAlcohol 85.6 mL/100mLSolutionTopicalSC Johnson Professional USA Inc.11084-009
Always Save Bacitracin Zincbacitracin zincBacitracin zinc 500 [USP'U]/gOintmentTopicalTrifecta Pharmaceuticals USA LLC69396-148
American Safety and First Aid Triple Antibioticbacitracin zinc, neomycin sulfate, polymyxin b sulfateBacitracin zinc 400 [USP'U]/g + 2 more ingredientsOintmentTopicalOrazen Inc71927-016
American Safety First Aid Antispeticisopropyl alcoholIsopropyl alcohol 700 mg/1000mLSprayTopicalOrazen Inc71927-014
Anti-Itch with Aloehydrocortisone 1%Hydrocortisone 1 g/100gCreamTopicalChain Drug Marketing Association Inc.83324-046
Antibacterial Hand Wipes (0.13% Benzalkonium Chloride)benzalkonium chlorideBenzalkonium chloride 5.2 mg/1ClothTopicalEleeo Brands LLC79747-013
AntibioticbacitracinBacitracin 500 [USP'U]/gOintmentTopicalTopco Associates LLC36800-536
antibioticneomycin, polymyxin b, pramoxine hclNeomycin sulfate 3.5 mg/g + 2 more ingredientsCreamTopicalH E B37808-005
Antibioticbacitracin zinc, polymyxin b sulfateBacitracin zinc 500 [iU]/g; Polymyxin b sulfate 10000 [iU]/gOintmentTopicalCVS PHARMACY, INC51316-044
Antibioticneomycin sulfateNeomycin sulfate 3.5 mg/gOintmentTopicalTotal Resources International55550-730
Antibioticbacitracin zinc, neomycin, polymyxin bBacitracin zinc 400 [USP'U]/g + 2 more ingredientsOintmentTopicalCVS Pharmacy69842-199
Antibioticbacitracin zinc, neomycin sulfate, polymyxin b sulfateBacitracin zinc 6 mg/mL + 2 more ingredientsOintmentTopicalWelly Health PBC72663-560
Antibiotic and Pain Reliefneomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloridePolymyxin b sulfate 10000 [USP'U]/g + 2 more ingredientsCreamTopicalTarget Corporation11673-770
Antibiotic and Pain Reliefneomycin, polymyxin b, pramoxine hydrochlorideNeomycin sulfate 3.5 mg/g + 2 more ingredientsCreamTopicalCVS Pharmacy69842-754
Antibiotic Maximum Strengthbacitracin zinc, neomycin sulfate, polymyxin b sulfateBacitracin zinc 500 [iU]/g + 2 more ingredientsOintmentTopicalWalgreens0363-0018
ANTIBIOTIC Maximum Strengthbacitracin zinc, neomycin sulfate, polymyxin b sulfateBacitracin zinc 500 [iU]/g + 2 more ingredientsOintmentTopicalWalgreens Co.0363-1331
antibiotic plus pain reliefneomycin, polymyxin b, pramoxine hydrochlorideNeomycin sulfate 3.5 mg/g + 2 more ingredientsCreamTopicalKroger Company30142-790

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