Prescription drug · NDA
Amzeeq (minocycline) NDC 69489-201
Minocycline hydrochloride 40 mg/g · Aerosol, Foam · Topical · Journey Medical Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69489-201-03 | 69489020103 | 1 CAN in 1 CARTON (69489-201-03) / 3 g in 1 CANMarketed from Jan 25, 2023 · Sample package | |
| 69489-201-30 | 69489020130 | 1 CAN in 1 CARTON (69489-201-30) / 30 g in 1 CANMarketed from Mar 25, 2022 |
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)
- Amzeeq
- Generic name (nonproprietary)
- minocycline
- Active ingredients
- Minocycline hydrochloride — 40 mg/g
- Dosage form
- Aerosol, Foam
- Route
- Topical
- Labeler
- Journey Medical Corporation
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212379
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Prothrombin Activity (Physiologic effect)Tetracyclines (Chemical structure)
- Identifiers
- Product ID 69489-201_28ee8ff9-b982-4e9d-e063-6294a90a900cSPL ID 28ee8ff9-b982-4e9d-e063-6294a90a900cSPL set ID cc251492-977b-4eb1-a088-a90831324badRxCUI 2257673, 2257678UNII 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
N469489020103followed by a unit qualifier and the quantityPackage 69489-0201-03. 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)
AMZEEQ is indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older [ 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, AMZEEQ should be used only as indicated [ see Warnings and Precautions ( 5.14 ) ]. AMZEEQ is a tetracycline-class drug indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. ( 1 ) Limitation…
Excerpt only. Read the full label for complete information.