Prescription drug · NDA AUTHORIZED GENERIC
hydrocortisone and acetic acid (Hydrocortisone and acetic acid otic) NDC 71656-064
Acetic acid 20.75 mg/mL; Hydrocortisone 10.375 mg/mL · Solution · Auricular (Otic) · Saptalis Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71656-064-10 | 7165600641071656006410 | 1 BOTTLE, DROPPER in 1 CARTON (71656-064-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Feb 23, 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)
- hydrocortisone and acetic acid
- Generic name (nonproprietary)
- hydrocortisone and acetic acid otic
- Active ingredients
- Acetic acid — 20.75 mg/mLHydrocortisone — 10.375 mg/mL
- Dosage form
- Solution
- Route
- Auricular (Otic)
- Labeler
- Saptalis Pharmaceuticals, LLCNDC labeler code 71656
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 012770
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 71656-064_339e0417-4d1a-e168-e063-6294a90a50bbSPL ID 339e0417-4d1a-e168-e063-6294a90a50bbSPL set ID d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32RxCUI 313786UNII Q40Q9N063P, WI4X0X7BPJ
- Pharmacologic class
- Corticosteroid
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
N471656006410followed by a unit qualifier and the quantityPackage 71656-0064-10. 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, complicated by inflammation.
Excerpt only. Read the full label for complete information.
About NDC 71656-064
- What is NDC 71656-064?
- 71656-064 is the product NDC for hydrocortisone and acetic acid, Acetic acid 20.75 mg/mL; Hydrocortisone 10.375 mg/mL solution, listed with the FDA by Saptalis Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- hydrocortisone and acetic acid (Hydrocortisone and acetic acid otic).
- What is the active ingredient?
- Acetic acid, Hydrocortisone.
- Who is the labeler?
- Saptalis Pharmaceuticals, LLC, NDC labeler code 71656. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for hydrocortisone and acetic acid?
- 2 other product NDCs are listed under this name. See all hydrocortisone and acetic acid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other hydrocortisone and acetic acid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| hydrocortisone and acetic acid | Acetic acid 20 mg/mL; Hydrocortisone 10 mg/mL | SolutionAuricular (Otic) | Cosette Pharmaceuticals, Inc. | 0713-0849 | 00713-0849-09 |
| Hydrocortisone and Acetic Acid | Hydrocortisone 10.4 mg/mL; Acetic acid 20.8 mg/mL | SolutionAuricular (Otic) | Sun Pharmaceutical Industries, Inc. | 51672-3007 | 51672-3007-01 |