What is NDC 78003-140?

78003-140 is the product NDC for HydrAphex, Benzalkonium chloride .0013 g/mL solution, listed with the FDA by Aphex Biocleanse Systems, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aphex Biocleanse Systems, Inc, NDC labeler code 78003. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for HydrAphex?

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.

HydrAphex NDC 78003-140 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)78003-140Labeler and product segments. Claims need a package NDC.

Product NDC at billing width78003-0140Add 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
78003-140-70	7800301407078003014070	208000 mL in 1 DRUM (78003-140-70)Marketed from Jun 1, 2020
78003-140-80	7800301408078003014080	1045000 mL in 1 CONTAINER (78003-140-80)Marketed from Jun 1, 2020

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): HydrAphex
Generic name (nonproprietary): hydraphex
Active ingredients: Benzalkonium chloride — .0013 g/mL
Dosage form: Solution
Route: Topical
Labeler: Aphex Biocleanse Systems, IncNDC labeler code 78003
Product type: Over-the-counter drug
Marketing category: OTC monograph (not final)Application part333A
Marketing start: Jun 1, 2012
Marketing end: Jan 31, 2029
Identifiers: Product ID 78003-140_d5ccc62d-3d96-650c-e053-2a95a90a5e17SPL ID d5ccc62d-3d96-650c-e053-2a95a90a5e17SPL set ID a6035c7d-0f5b-3295-e053-2995a90af89cUNII F5UM2KM3W7UPC 0850608003329

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

N478003014070 followed by a unit qualifier and the quantity

Package 78003-0140-70. 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 Jan 17, 2022.

Indications (excerpt from the label)

Usage Section Uses : For hand sanitizing. Helps prevent the risk and spread of infection as well as communicable diseases by killing germs that reside on the surface of the skin.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 78003-140

What is NDC 78003-140?: 78003-140 is the product NDC for HydrAphex, Benzalkonium chloride .0013 g/mL solution, listed with the FDA by Aphex Biocleanse Systems, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: HydrAphex.
What is the active ingredient?: Benzalkonium chloride.
Who is the labeler?: Aphex Biocleanse Systems, Inc, NDC labeler code 78003. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for HydrAphex?: 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 part333A

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

FDA NDC Directory listings under part333A
Product	Strength	Form · route	Labeler	Product NDC
Foaming Mousse Anti-Bacterial Hand Sanitizer Cherry Scentedalcohol	Alcohol 62 mL/100mL	Aerosol, FoamTopical	Ganzhou Olivee Cosmetic Co., Ltd.	56136-021
Antimicrobial Hand Washchloroxylenol	Chloroxylenol 6 mg/1000mL	SoapTopical	Henry Schein, Inc.	0404-5990
TOUCH Sanitizing Germ Block, Ocean Mist, 1oz (28.35g)benzalkonium chloride	Benzalkonium chloride .13 g/100g	Aerosol, SprayTopical	Relevo, Inc.	69744-0204
Hand Wipeschlorhexidine digluconate and benzethonium chloride	Chlorhexidine gluconate .1 g/g; Benzethonium chloride .08 g/g	ClothTopical	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	71734-203
Callington Anti-Bacterial Hand Sanitiserbenzalkonium chloride	Benzalkonium chloride .05 g/g	ClothTopical	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	71734-210
CPAP Mask cleaning wipesbenzethonium chloride and benzalkonium chloride	Benzethonium chloride .03 g/g; Benzalkonium chloride .02 g/g	ClothTopical	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	71734-212
Antimicrobial Hand Washchloroxylenol	Chloroxylenol 6 mg/1000mL	SoapTopical	Henry Schein, Inc.	0404-5987
KONIX Alcohol Antiseptic Hand Rub	Alcohol 70 mL/100mL	SolutionTopical	TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS	73107-105
Byotrol Hand Sanitizerbenzalkonium chloride	Benzalkonium chloride 1.3 mg/mL	LiquidTopical	Advanced Hygienics LLC	63002-002
Hand Sanitizerbenzalkonium chloride	Benzalkonium chloride 1.3 g/mL	SolutionTopical	Advanced Hygienics LLC	63002-004
Foaming Mousse Anti-Bacterial Hand Sanitizer Pineapple Scentedalcohol	Alcohol 62 mL/100mL	Aerosol, FoamTopical	Ganzhou Olivee Cosmetic Co., Ltd.	56136-022
Foaming Mousse Anti-Bacterial Hand Sanitizer Pink Grapefruit Scentedalcohol	Alcohol 62 mL/100mL	Aerosol, FoamTopical	Ganzhou Olivee Cosmetic Co., Ltd.	56136-023
CVS Hand Sanitizeralcohol	Alcohol 56 mg/g	SprayTopical	CVS	69842-557
BZK Towelettebenzalkonium chloride	Benzalkonium chloride 1.33 mg/mL	SwabTopical	Acme United Corporation	0924-7112
Mistalcohol	Alcohol 62 mL/100mL	SprayTopical	Derma Glove	70741-003
Mistalcohol	Alcohol 62 mL/100mL	SprayTopical	Derma Glove	70741-003
Mistalcohol	Alcohol 62 mL/100mL	SprayTopical	Derma Glove	70741-003
Mistalcohol	Alcohol 62 mL/100mL	SprayTopical	Derma Glove	70741-003
Handlotion	Alcohol 70 mL/100mL	LotionTopical	Derma Glove	70741-006
Soft Care Sentrybenzalkonium chloride	Benzalkonium chloride .13 g/100mL	SolutionTopical	Diversey, Inc.	64536-1948

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