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	8051308130680513081306	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, 2027
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
Pramoxine Hydrochloride Anorectalpramoxine hydrochloride	Pramoxine hydrochloride 1 mg/mL	LotionTopical	Stratus Pharmaceuticals	58980-522
Ma Ying Long Musk Hemorrhoidspetrolatum, zinc oxide	Petrolatum 779.9 mg/g; Zinc oxide 76 mg/g	OintmentTopical	Mayinglong Pharmaceutical Group Co., Ltd.	68511-997
Mayinglong Hemorrhoidalpetrolatum, zinc oxide	Petrolatum 779.9 mg/g; Zinc oxide 76 mg/g	OintmentTopical	Mayinglong Pharmaceutical Group Co., Ltd.	68511-998
hemorrhoidal maximum strength pain reliefglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum	Glycerin 14.4 g/100g + 3 more ingredients	CreamTopical	Kroger Company	30142-944
Preparation Hcocoa butter, phenylephrine hydrochloride, and witch hazel	—	Kit	Haleon US Holdings LLC	0573-2884
Hemorrhoidalmineral oil, petrolatum, phenylephrine hcl	Mineral oil 14 g/100g + 2 more ingredients	OintmentRectal	Kroger Company	30142-188
rexall hemorrhoidalcocoa butter, phenylephrine hcl	Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1	SuppositoryRectal	Dolgencorp Inc	55910-279
Witch Hazel	Witch hazel 860 mg/mL	LiquidTopical	CVS Pharmacy, Inc.	59779-045
Dermatool Hemorrhoidalglycerin, lidocaine, petrolatum, phenylephrine hcl	Lidocaine 5 g/100g + 3 more ingredients	CreamTopical	Papalo Group LLC	84728-413
Acolye Numbing Cream Anorectal(Hemorrhoidal) Creamlidocaine	Lidocaine 5 g/100g	CreamTopical	Guangzhou Haishi Biological Technology Co., Ltd.	60771-0028
Hemorrhoid Anestheticmineral oil, petrolatum, phenylephrine hcl	Petrolatum .749 g/g + 2 more ingredients	OintmentTopical	Savvy Care and Cosmetics	83650-110
hemorrhoidalcocoa butter, phenylephrine hcl	Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1	SuppositoryRectal	Meijer Distribution Inc	41250-279
Lidocaine Numbing Creamlidocaine	Lidocaine .05 g/g	CreamTopical	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	73557-311
RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream)lidocaine	Lidocaine 5 g/100g	CreamTopical	Guangzhou Haishi Biological Technology Co., Ltd.	60771-0027
Barrier Protectant Creambarrier cream	Menthol 1 mg/g; Zinc oxide 200 mg/g	OintmentTopical	Cardinal Health	63517-003
ER Hemorrhoidphenylephrine hcl	Mineral oil .14 g/g + 2 more ingredients	CreamRectal	EVER READY FIRST AID	72976-018
ANIXIKE Numbinglidocaine4% numbing	Lidocaine 4 g/100g	CreamTopical	Jiangxi Yudexi Pharmaceutical Co., LTD	85248-166
Meijer Maximum strength pain relieving cleansingbenzalkonium chloride and lidocaine hydrochloride	Benzalkonium chloride .13 g/100mL; Lidocaine hydrochloride 4 g/100mL	LiquidTopical	MEIJER DISTRIBUTION, INC.	41250-287
hemorrhoidalglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum	Glycerin 14.4 g/100g + 3 more ingredients	CreamTopical	Meijer Distribution Inc	41250-944
Equaline Hemorrhoidalcocoa butter, phenylephrine hcl	Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1	SuppositoryRectal	United Natural Foods, Inc. dba UNFI	41163-279

Showing 20 of 40.

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