Prescription drug · ANDA
Acetic Acid NDC 52817-816
Acetic acid 20.65 mg/mL · Solution · Auricular (Otic) · TruPharma, LLC
NDC codes
FDA NDC Directory| 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, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040607
- Marketing start
- Listing expires
- 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
N452817081615followed by a unit qualifier and the quantityPackage 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 .
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.
Other NDCs under ANDA 040607
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Acetic Acid | Acetic acid 20.65 mg/mL | SolutionAuricular (Otic) | NuCare Pharmaceuticals,Inc. | 68071-2984 |
| Acetic Acid | Acetic acid 20.65 mg/mL | SolutionAuricular (Otic) | A-S Medication Solutions | 50090-6527 |