NDC codes

FDA NDC Directory
Product NDC (as listed)76348-409Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76348-0409Add 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
76348-409-0276348040902763480409021 BOTTLE, PUMP in 1 BOX (76348-409-02) / 28 g in 1 BOTTLE, PUMPMarketed from Aug 20, 2015

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)
Dr. Canuso foot repair serum
Generic name (nonproprietary)
tolnaftate serum
Active ingredients
Tolnaftate — .3 g/28g
Dosage form
Lotion
Route
Topical
Labeler
Renu Laboratories, LLCNDC labeler code 76348
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 005
Marketing start
Listing expires
Identifiers
Product ID 76348-409_350b8fbb-d869-9503-e063-6394a90a9eb8SPL ID 350b8fbb-d869-9503-e063-6394a90a9eb8SPL set ID 1fcc52c5-7030-13cb-e054-00144ff8d46cRxCUI 283693UNII 06KB629TKV

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

N476348040902 followed by a unit qualifier and the quantity

Package 76348-0409-02. 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)

Directions Apply two pumps of serum onto each foot morning and night, paying special attention to rough cracked skin. For maintenance of smooth skin, massage two pumps of serum into each foot once daily. Supervise children in the use of this product.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76348-409

What is NDC 76348-409?
76348-409 is the product NDC for Dr. Canuso foot repair serum (tolnaftate serum), Tolnaftate .3 g/28g lotion, listed with the FDA by Renu Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dr. Canuso foot repair serum (Tolnaftate serum).
What is the active ingredient?
Tolnaftate.
Who is the labeler?
Renu Laboratories, LLC, NDC labeler code 76348. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dr. Canuso foot repair serum?
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 005

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

FDA NDC Directory listings under M 005
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Eyelid Wipes4-terpineol .003 U/100U; Melaleuca alternifolia (Tea tree) leaf oil .04 U/100UClothTopicalShenzhen Shierjie Biological Engineering Co., LTD43116-040
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Terrasil Ringworm Treatment MAXclotrimazoleClotrimazole 1 g/100gOintmentTopicalAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions24909-102
Clotrimazolefamily wellness clotrimazoleClotrimazole 1 g/100gCreamTopicalTrifecta Pharmaceuticals USA LLC69396-038
Paume Moisturizing Antibacterial Hand GelalcoholAlcohol 69 mL/100mLGelTopicalPaume Inc80328-123
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ClotrimazoleClotrimazole 1 g/100gCreamTopicalA-S Medication Solutions50090-6546
RoyceDerm ANTIFUNGAL .soap.clotrimazole 1%Clotrimazole 2.26 g/226gSoapTopicalRoyceDerm LLC85424-019
1% ketoconazole anti dandruff1% ketoconazole anti dandruff shampooKetoconazole 1 g/100mLShampooCutaneousFast Sold LLC86241-110
Charmpoo ANTIFUNGAL BODY Creammiconazole nitrate 2% antifungal body creamMiconazole nitrate 2 g/100gCreamTopicalWenzhou Yuyuan Pharmaceutical Co., Ltd.87786-042

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