What is NDC 39328-079?

39328-079 is the product NDC for Flac Otic Oil (fluocinolone acetonide), Fluocinolone acetonide .11 mg/mL oil, listed with the FDA by Patrin Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Flac Otic Oil (Fluocinolone acetonide).

Patrin Pharma, Inc., NDC labeler code 39328. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Flac Otic Oil?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Flac Otic Oil NDC 39328-079 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)39328-079Labeler and product segments. Claims need a package NDC.

Product NDC at billing width39328-0079Add 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
39328-079-20	3932800792039328007920	1 BOTTLE, DROPPER in 1 CARTON (39328-079-20) / 20 mL in 1 BOTTLE, DROPPERMarketed from Apr 12, 2018

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): Flac Otic Oil
Generic name (nonproprietary): fluocinolone acetonide
Active ingredients: Fluocinolone acetonide — .11 mg/mL
Dosage form: Oil
Route: Auricular (Otic)
Labeler: Patrin Pharma, Inc.NDC labeler code 39328
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210736
Marketing start: Apr 12, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 39328-079_b9a91a1b-2c51-4ef3-8152-7a720061b5aaSPL ID b9a91a1b-2c51-4ef3-8152-7a720061b5aaSPL set ID 4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbbRxCUI 1191299, 2045201UNII 0CD5FD6S2M
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

N439328007920 followed by a unit qualifier and the quantity

Package 39328-0079-20. 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 Nov 19, 2024.

Indications (excerpt from the label)

INDICATION AND USAGE Fluocinolone acetonide oil, 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 39328-079

What is NDC 39328-079?: 39328-079 is the product NDC for Flac Otic Oil (fluocinolone acetonide), Fluocinolone acetonide .11 mg/mL oil, listed with the FDA by Patrin Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Flac Otic Oil (Fluocinolone acetonide).
What is the active ingredient?: Fluocinolone acetonide.
Who is the labeler?: Patrin Pharma, Inc., NDC labeler code 39328. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Flac Otic Oil?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Flac Otic Oil (Fluocinolone acetonide) NDC 39328-079