NDC codes

FDA NDC Directory
Product NDC (as listed)76348-970Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76348-0970Add 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
76348-970-01763480970011 BOTTLE, PUMP in 1 BOX (76348-970-01) / 50 mL in 1 BOTTLE, PUMP (76348-970-50)Marketed from Aug 8, 2022

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)
lidocaine 3 percent
Active ingredients
Lidocaine — 1.5 g/50mL
Dosage form
Liquid
Route
Topical
Labeler
Renu Laboratories, LLCNDC labeler code 76348
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 017
Marketing start
Listing expires
Other FDA classes
Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 76348-970_3492e688-b7e8-d380-e063-6294a90a329fSPL ID 3492e688-b7e8-d380-e063-6294a90a329fSPL set ID e5d64929-fb9c-7ebc-e053-2995a90a9318RxCUI 2607527UNII 98PI200987
Pharmacologic class
Amide Local Anesthetic; Antiarrhythmic

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

N476348097001 followed by a unit qualifier and the quantity

Package 76348-0970-01. 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 Temporarily relieves pain and itching due to sunburn minor burns minor cuts minor skin irritations

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76348-970

What is NDC 76348-970?
76348-970 is the product NDC for DermaRad Relief Post Radiation Calming, Lidocaine 1.5 g/50mL liquid, 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?
DermaRad Relief Post Radiation Calming (Lidocaine 3 percent).
What is the active ingredient?
Lidocaine.
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 DermaRad Relief Post Radiation Calming?
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 017

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

FDA NDC Directory listings under M 017
ProductStrengthForm · routeLabelerProduct NDC
0.5% Lidocaine Burn Relieflidocaine hydrochlorideLidocaine hydrochloride .5 g/100gGelTopicalNantong Health & Beyond Hygienic Products Inc.43473-099
0.5% Lidocaine Burn Relieflidocaine hydrochlorideLidocaine hydrochloride .5 g/100gGelTopicalUniversal Distribution Center LLC52000-437
1% Hydrocortisone Anti-itchHydrocortisone 10 mg/gCreamTopicalALAINA HEALTHCARE PRIVATE LIMITED73492-291
10% Methyl Salicylate Pain Relief Patch10% methyl salicylateMethyl salicylate 10 mg/100mgTapeTopicalAkron Coating & Adhesives65604-222
11681168 burn sprayLidocaine hydrochloride .02 mg/mLSprayTopicalDynarex Corporation67777-013
2.0% Lidocaine Burnlidocaine hydrochlorideLidocaine hydrochloride 2 g/100mLSprayTopicalNantong Health & Beyond Hygienic Products Inc.43473-097
2.0% Lidocaine Burnlidocaine hydrochlorideLidocaine hydrochloride 2 g/100mLSprayTopicalUniversal Distribution Center LLC52000-441
2.5% Menthol PAIN RELIEFmentholMenthol, Unspecified form 25 mg/gGelTopicalNantong Health & Beyond Hygienic Products Inc.43473-096
2.5% Menthol PAIN RELIEFmentholMenthol, Unspecified form 25 mg/gGelTopicalUniversal Distribution Center LLC52000-440
24 7 Relief and Recovery Pain Relievingmenthol, unspecified formMenthol, Unspecified form 37 mg/mLCreamTopicalTriplicare Inc87656-964
2677 First Aid Burn CreamBenzalkonium chloride 13 mg/10000mg; Lidocaine hydrochloride 50 mg/10000mgCreamTopicalProStat First Aid LLC58228-2677
2nd CHANCE MOBILITY Pain Reliefhistamine dihydrochlorideHistamine dihydrochloride .5 mg/gCreamTopicalALPHA NUTRITION, LLC83984-441
365 Medicated Lip Balmmedicated lip balmCamphor (Natural) .0578 g/4.25gStickTopicalWhole Foods Market, Inc.42681-0001
3X Medicated Toothache and Gum GelbenzocaineBenzocaine 20 g/100g + 2 more ingredientsGelOralRite Aid11822-0613
4 Lidocaine Topical AnestheticlidocaineLidocaine 40 mg/gCreamTopicalRUGBY LABORATORIES0536-1267
4% Lidocaine Maximum Strength Pain RelieflidocaineLidocaine .04 g/1PatchTopicalShenzhen Finona Information Technology Co., Ltd85839-011
4% Lidocaine Pain Relief Patchlidocaine 4%Lidocaine .04 g/1PatchTransdermalGuangxi Keyun E-commerce Co., Ltd.87278-003
4% Lidocaine Pain Relief Patchlidocaine 4%Lidocaine .04 g/1PatchTransdermalGuangxi Keyun E-commerce Co., Ltd.87278-020
4% Lidocaine Patches4% lidocaineLidocaine 40 mg/1PatchTopicalShenzhen Huayuan Hengsheng Technology Co., Ltd.87394-002
4% Lidocaine PatchesLidocaine 4 g/1001PatchTopicalShenzhen Chaoxiji Technology Co.,Ltd.87794-006

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