NDC codes

FDA NDC Directory
Product NDC (as listed)69489-212Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69489-0212Add 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 NDC11-digit (billing)PackageCopy
69489-212-03694890212031 CAN in 1 CARTON (69489-212-03) / 3 g in 1 CANMarketed from Nov 1, 2023 · Sample package
69489-212-30694890212301 CAN in 1 CARTON (69489-212-30) / 30 g in 1 CANMarketed from Jun 1, 2023

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)
Zilxi
Generic name (nonproprietary)
minocycline
Active ingredients
Minocycline hydrochloride — 15 mg/g
Dosage form
Aerosol, Foam
Route
Topical
Labeler
Journey Medical CorporationNDC labeler code 69489
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 213690
Marketing start
Listing expires
Other FDA classes
Decreased Prothrombin Activity (Physiologic effect)Tetracyclines (Chemical structure)
Identifiers
Product ID 69489-212_e5d4b4fa-1951-4fa8-9677-acb97b10c087SPL ID e5d4b4fa-1951-4fa8-9677-acb97b10c087SPL set ID cbffa96e-2446-43cf-ba5e-38c645302afdRxCUI 2375333, 2375338UNII 0020414E5U
Pharmacologic class
Tetracycline-class Drug

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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469489021203 followed by a unit qualifier and the quantity

Package 69489-0212-03. 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)

ZILXI is indicated for the treatment of inflammatory lesions of rosacea in adults [see Clinical Studies ( 14 )] . Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, ZILXI should be used only as indicated [see Warnings and Precautions ( 5.14 )] . ZILXI is a tetracycline-class drug indicated for the treatment of inflammatory lesions of rosacea in adults. ( 1 ) Limitations of Use This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69489-212

What is NDC 69489-212?
69489-212 is the product NDC for Zilxi (minocycline), Minocycline hydrochloride 15 mg/g aerosol, foam, listed with the FDA by Journey Medical Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Zilxi (Minocycline).
What is the active ingredient?
Minocycline hydrochloride.
Who is the labeler?
Journey Medical Corporation, NDC labeler code 69489. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zilxi?
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.

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