What is NDC 0338-0656?

0338-0656 is the product NDC for Acetic Acid, Acetic acid 250 mg/100mL irrigant, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

Baxter Healthcare Corporation, NDC labeler code 0338. 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 0338-0656 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0338-0656Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00338-0656Add 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
0338-0656-04	0033806560400338065604	1000 mL in 1 BOTTLE, PLASTIC (0338-0656-04)Marketed from Feb 19, 1982

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 250 mg/100mL
Dosage form: Irrigant
Route: Irrigation
Labeler: Baxter Healthcare CorporationNDC labeler code 0338
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 018523
Marketing start: Feb 19, 1982
Listing expires: Dec 31, 2027
Identifiers: Product ID 0338-0656_87782b03-c260-4e1d-b96e-8f5aa94411e2SPL ID 87782b03-c260-4e1d-b96e-8f5aa94411e2SPL set ID 41bc12af-fac5-4ac1-b907-dcb3e35a054cRxCUI 307707UNII 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

N400338065604 followed by a unit qualifier and the quantity

Package 00338-0656-04. 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 Feb 2, 2018.

Indications (excerpt from the label)

INDICATIONS AND USAGE 0.25% Acetic Acid Irrigation, USP, is indicated as a constant or intermittent bladder rinse to help prevent the growth and proliferation of susceptible urinary pathogens (especially ammonia forming bacteria) in the management of patients who require prolonged placement of an indwelling urethral catheter. It also may be used for periodic irrigation of an indwelling catheter to help maintain patency by reducing the formation of calcium encrustations.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0338-0656

What is NDC 0338-0656?: 0338-0656 is the product NDC for Acetic Acid, Acetic acid 250 mg/100mL irrigant, listed with the FDA by Baxter Healthcare Corporation. 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?: Baxter Healthcare Corporation, NDC labeler code 0338. 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)	TruPharma, LLC	52817-816	52817-0816-15
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 .25 g/100mL	IrrigantIrrigation	B. Braun Medical Inc.	0264-2304	00264-2304-0000264-2304-10