What is NDC 80513-813?

80513-813 is the product NDC for PUREGEN LABS Maximum Strength Lidocaine, Lidocaine 50 mg/g cream, listed with the FDA by Advanced Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

PUREGEN LABS Maximum Strength Lidocaine (Lidocaine).

Advanced Rx LLC, NDC labeler code 80513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for PUREGEN LABS Maximum Strength Lidocaine?

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.

PUREGEN LABS Maximum Strength Lidocaine NDC 80513-813

NDC codes

FDA NDC Directory

Product NDC (as listed)80513-813Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80513-0813Add 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 NDC	11-digit (billing)	Package	Copy
80513-813-06	80513081306	170 g in 1 TUBE (80513-813-06)Marketed from Apr 22, 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): PUREGEN LABS Maximum Strength Lidocaine
Generic name (nonproprietary): lidocaine
Active ingredients: Lidocaine — 50 mg/g
Dosage form: Cream
Route: Topical
Labeler: Advanced Rx LLCNDC labeler code 80513
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 015
Marketing start: Apr 22, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 80513-813_15cfdc73-c2f3-528e-e063-6394a90a07aeSPL ID 15cfdc73-c2f3-528e-e063-6394a90a07aeSPL set ID f4f89582-49e6-424a-bea7-0694484a7c99RxCUI 1366789UNII 98PI200987UPC 0380513001054
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

N480513081306 followed by a unit qualifier and the quantity

Package 80513-0813-06. 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 Apr 11, 2024.

Indications (excerpt from the label)

Uses Helps relieve the local itching and discomfort in the perianal area For the temporary relief of pain, irritation” or burning.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80513-813

What is NDC 80513-813?: 80513-813 is the product NDC for PUREGEN LABS Maximum Strength Lidocaine, Lidocaine 50 mg/g cream, listed with the FDA by Advanced Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: PUREGEN LABS Maximum Strength Lidocaine (Lidocaine).
What is the active ingredient?: Lidocaine.
Who is the labeler?: Advanced Rx LLC, NDC labeler code 80513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for PUREGEN LABS Maximum Strength Lidocaine?: 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 015

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

FDA NDC Directory listings under M 015
Product	Strength	Form · route	Labeler	Product NDC
NUMB PLUS Maximum Strength Anorectallidocaine	Lidocaine 50 mg/mL	GelTopical	SEENEXT VENTURE LTD	70907-098
tina davies IceJelly Hemorrhoidallidocaine, phenylephrine hydrochloride	Lidocaine 5 g/100mL; Phenylephrine hydrochloride .25 g/100mL	CreamTopical	TINA DAVIES PROFESSIONAL LLC	84313-101
Hemorrohoid Master Creamlidocaine, phenylephrine hcl	Lidocaine 50 mg/g; Phenylephrine hydrochloride 2.5 mg/g	CreamTopical	Ebanel Laboratories, Inc.	72654-038
Leader Maximum Strength Hemorrhoidal Relieflidocaine	Lidocaine 50 mg/g	CreamTopical	Cardinal Health,Inc.	70000-0650
Tina Davies IceCreamlidocaine hydrochloride, phenylephrine hydrochloride	Lidocaine hydrochloride 5 g/100mL; Phenylephrine hydrochloride .25 g/100mL	CreamTopical	TINA DAVIES PROFESSIONAL LLC	84313-001
Numb25lidocaine	Lidocaine 50 mg/g	CreamTopical	Ebanel Laboratories, Inc.	72654-036
tina davies IceCream Hemorrhoidallidocaine, phenylephrine hydrochloride	Lidocaine 5 g/100mL; Phenylephrine hydrochloride .25 g/100mL	CreamTopical	TINA DAVIES PROFESSIONAL LLC	84313-002
Numb520Spraylidocaine, phenylephrine hcl	Lidocaine 50 mg/mL; Phenylephrine hydrochloride 2.5 mg/mL	LiquidTopical	Ebanel Laboratories, Inc.	72654-037
Equate Hemorrhoid Relieflidocaine	Lidocaine 50 mg/g	CreamTopical	Walmart Inc.	79903-428
SCALAR Pain Relief Creammenthol	Menthol 50 mg/mL	CreamTopical	Miracle Balance, LLC	80883-097
Hemorrhoidalmineral oil, petrolatum, phenylephrine hcl	Mineral oil 14 g/100g + 2 more ingredients	OintmentRectal	Kroger Company	30142-188
Family Wellnessglycerin, phenylephrine hydrochloride, pramoxine hydrochloride, petrolatum	Glycerin 14.4 g/100g + 3 more ingredients	CreamTopical	Zhejiang Jingwei Pharmaceutical Co., Ltd.	55621-012
Equaline Hemorrhoidalmineral oil, petrolatum, phenylephrine hcl	Mineral oil 14 g/100g + 2 more ingredients	OintmentRectal	United Natural Foods, Inc. dba UNFI	41163-188
Hemorrhoidalmineral oil, petrolatum, phenylephrine hydrochloride	Mineral oil 14 g/100g + 2 more ingredients	OintmentRectal	Safeway	21130-687
Flarestop Hemorrhoid Lidocainelidocaine	Lidocaine 50 mg/g	CreamTopical	Chelsea Pharmacceuticals LLC	87989-013
hemorrhoidal maximum strength pain reliefglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum	Glycerin 14.4 g/100g + 3 more ingredients	CreamTopical	Kroger Company	30142-944
Witch Hazel	Witch hazel 860 mg/mL	LiquidTopical	ADUSA Distribution, LLC	41520-822
lidocaine	Lidocaine 50 mg/g	CreamTopical	Nivagen Pharmaceuticals, Inc.	75834-333
Medlinementhol, white petrolatum, zinc oxide	Zinc oxide 206 mg/g + 2 more ingredients	PasteTopical	Medline Industries, LP	53329-156
Family Wellness HEMORRHOIDglycerin, petrolatum, phenylephrine hcl, pramoxine hcl	Glycerin 144 mg/g + 3 more ingredients	CreamTopical	FAMILY DOLLAR (Family Wellness)	55319-981

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PUREGEN LABS Maximum Strength Lidocaine (Lidocaine) NDC 80513-813