What is NDC 0713-0849?

0713-0849 is the product NDC for hydrocortisone and acetic acid, Acetic acid 20 mg/mL; Hydrocortisone 10 mg/mL solution, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cosette Pharmaceuticals, Inc., NDC labeler code 0713. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

hydrocortisone and acetic acid NDC 0713-0849

NDC codes

FDA NDC Directory

Product NDC (as listed)0713-0849Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00713-0849Add 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
0713-0849-09	0071308490900713084909	1 BOTTLE in 1 CARTON (0713-0849-09) / 10 mL in 1 BOTTLEMarketed from Feb 1, 2024

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): hydrocortisone and acetic acid
Generic name (nonproprietary): hydrocortisone and acetic acid
Active ingredients: Acetic acid — 20 mg/mLHydrocortisone — 10 mg/mL
Dosage form: Solution
Route: Auricular (Otic)
Labeler: Cosette Pharmaceuticals, Inc.NDC labeler code 0713
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040609
Marketing start: Feb 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0713-0849_106bf241-c85e-8985-e063-6394a90abffbSPL ID 106bf241-c85e-8985-e063-6394a90abffbSPL set ID cef3713f-11f3-4723-9267-3d79855b49bfRxCUI 313786UNII Q40Q9N063P, WI4X0X7BPJUPC 0307130849098
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

N400713084909 followed by a unit qualifier and the quantity

Package 00713-0849-09. 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, 2024.

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.

Full label on DailyMed (opens in a new tab)

About NDC 0713-0849

What is NDC 0713-0849?: 0713-0849 is the product NDC for hydrocortisone and acetic acid, Acetic acid 20 mg/mL; Hydrocortisone 10 mg/mL solution, listed with the FDA by Cosette Pharmaceuticals, 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?: Acetic acid, Hydrocortisone.
Who is the labeler?: Cosette Pharmaceuticals, Inc., NDC labeler code 0713. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other hydrocortisone and acetic acid NDCs
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	Hydrocortisone 10.4 mg/mL; Acetic acid 20.8 mg/mL	SolutionAuricular (Otic)	Sun Pharmaceutical Industries, Inc.	51672-3007	51672-3007-01