Prescription drug · ANDA
Hydrocortisone and Acetic Acid NDC 51672-3007
Hydrocortisone 10.4 mg/mL; Acetic acid 20.8 mg/mL · Solution · Auricular (Otic) · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-3007-1 | 5167230070151672300701 | 1 BOTTLE in 1 CARTON (51672-3007-1) / 10 mL in 1 BOTTLEMarketed from Apr 28, 2005 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Active ingredients
- Hydrocortisone — 10.4 mg/mLAcetic acid — 20.8 mg/mL
- Dosage form
- Solution
- Route
- Auricular (Otic)
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088759
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 51672-3007_395a20ab-856b-3f08-e063-6294a90aa48eSPL ID 395a20ab-856b-3f08-e063-6294a90aa48eSPL set ID 6383c722-84e2-4719-a13d-19c54e3eefffUNII WI4X0X7BPJ, Q40Q9N063P
- 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
N451672300701followed by a unit qualifier and the quantityPackage 51672-3007-01. 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 51672-3007
- What is NDC 51672-3007?
- 51672-3007 is the product NDC for Hydrocortisone and Acetic Acid, Hydrocortisone 10.4 mg/mL; Acetic acid 20.8 mg/mL solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocortisone and Acetic Acid.
- What is the active ingredient?
- Hydrocortisone, Acetic acid.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. 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 acidhydrocortisone and acetic acid otic | Acetic acid 20.75 mg/mL; Hydrocortisone 10.375 mg/mL | SolutionAuricular (Otic) | Saptalis Pharmaceuticals, LLC | 71656-064 | 71656-0064-10 |
| hydrocortisone and acetic acid | Acetic acid 20 mg/mL; Hydrocortisone 10 mg/mL | SolutionAuricular (Otic) | Cosette Pharmaceuticals, Inc. | 0713-0849 | 00713-0849-09 |