Prescription drug · NDA
Zilxi (Minocycline) NDC 69489-212
Minocycline hydrochloride 15 mg/g · Aerosol, Foam · Topical · Journey Medical Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69489-212-03 | 69489021203 | 1 CAN in 1 CARTON (69489-212-03) / 3 g in 1 CANMarketed from Nov 1, 2023 · Sample package | |
| 69489-212-30 | 69489021230 | 1 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
N469489021203followed by a unit qualifier and the quantityPackage 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.
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.