NDC codes

FDA NDC Directory
Product NDC (as listed)62135-801Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0801Add 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 NDC11-digit (billing)PackageCopy
62135-801-516213508015115 mL in 1 BOTTLE (62135-801-51)Marketed from Mar 25, 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)
Acetic Acid
Generic name (nonproprietary)
acetic acid
Active ingredients
Acetic acid — 20 mg/mL
Dosage form
Solution
Route
Auricular (Otic)
Labeler
Chartwell RX, LLCNDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040166
Marketing start
Listing expires
Identifiers
Product ID 62135-801_149678b6-1fde-d54e-e063-6394a90a1eafSPL ID 149678b6-1fde-d54e-e063-6394a90a1eafSPL set ID 2aaf3781-4f25-4799-8dcd-78d67e226cccRxCUI 197305UNII Q40Q9N063PUPC 0362135801519

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

N462135080151 followed by a unit qualifier and the quantity

Package 62135-0801-51. 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 .

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 62135-801

What is NDC 62135-801?
62135-801 is the product NDC for Acetic Acid, Acetic acid 20 mg/mL solution, listed with the FDA by Chartwell RX, 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?
Chartwell RX, LLC, NDC labeler code 62135. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Acetic AcidAcetic acid 20.65 mg/mLSolutionAuricular (Otic)NuCare Pharmaceuticals,Inc.68071-298468071-2984-05
Acetic AcidAcetic acid 20.65 mg/mLSolutionAuricular (Otic)A-S Medication Solutions50090-652750090-6527-00
Acetic AcidAcetic acid 20.65 mg/mLSolutionAuricular (Otic)TruPharma, LLC52817-81652817-0816-15
Acetic AcidAcetic acid 20.65 mg/mLSolutionAuricular (Otic)NuCare Pharmaceuticals,Inc.68071-173968071-1739-05
Acetic AcidAcetic acid 250 mg/100mLIrrigantIrrigationBaxter Healthcare Corporation0338-065600338-0656-04
Acetic AcidAcetic acid .25 g/100mLIrrigantIrrigationB. Braun Medical Inc.0264-230400264-2304-0000264-2304-10

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