What is NDC 52817-816?

52817-816 is the product NDC for Acetic Acid, Acetic acid 20.65 mg/mL solution, listed with the FDA by TruPharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

TruPharma, LLC, NDC labeler code 52817. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Acetic Acid?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Acetic Acid NDC 52817-816 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)52817-816Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52817-0816Add 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
52817-816-15	52817081615	1 BOTTLE in 1 CARTON (52817-816-15) / 15 mL in 1 BOTTLEMarketed 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): Acetic Acid
Generic name (nonproprietary): acetic acid
Active ingredients: Acetic acid — 20.65 mg/mL
Dosage form: Solution
Route: Auricular (Otic)
Labeler: TruPharma, LLCNDC labeler code 52817
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040607
Marketing start: Jun 1, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 52817-816_2a4574f2-001a-ad0a-e063-6394a90a98f6SPL ID 2a4574f2-001a-ad0a-e063-6394a90a98f6SPL set ID 0c5ebd59-0e98-4ea1-b279-9202a19f6dbfRxCUI 197305UNII Q40Q9N063P

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N452817081615 followed by a unit qualifier and the quantity

Package 52817-0816-15. 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 Dec 27, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 52817-816

What is NDC 52817-816?: 52817-816 is the product NDC for Acetic Acid, Acetic acid 20.65 mg/mL solution, listed with the FDA by TruPharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Acetic Acid.
What is the active ingredient?: Acetic acid.
Who is the labeler?: TruPharma, LLC, NDC labeler code 52817. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Acetic Acid?: 6 other product NDCs are listed under this name. See all Acetic Acid NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Acetic Acid NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Acetic Acid	Acetic acid 20.65 mg/mL	SolutionAuricular (Otic)	NuCare Pharmaceuticals,Inc.	68071-2984	68071-2984-05
Acetic Acid	Acetic acid 20.65 mg/mL	SolutionAuricular (Otic)	A-S Medication Solutions	50090-6527	50090-6527-00
Acetic Acid	Acetic acid 20.65 mg/mL	SolutionAuricular (Otic)	NuCare Pharmaceuticals,Inc.	68071-1739	68071-1739-05
Acetic Acid	Acetic acid 20 mg/mL	SolutionAuricular (Otic)	Chartwell RX, LLC	62135-801	62135-0801-51
Acetic Acid	Acetic acid 250 mg/100mL	IrrigantIrrigation	Baxter Healthcare Corporation	0338-0656	00338-0656-04
Acetic Acid	Acetic acid .25 g/100mL	IrrigantIrrigation	B. Braun Medical Inc.	0264-2304	00264-2304-0000264-2304-10

Other NDCs under ANDA 040607

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

FDA NDC Directory listings under ANDA 040607
Product	Strength	Form · route	Labeler	Product NDC
Acetic Acid	Acetic acid 20.65 mg/mL	SolutionAuricular (Otic)	A-S Medication Solutions	50090-6527
Acetic Acid	Acetic acid 20.65 mg/mL	SolutionAuricular (Otic)	NuCare Pharmaceuticals,Inc.	68071-2984