Prescription drug · NDA
Azasite (azithromycin monohydrate) NDC 82584-307
Azithromycin monohydrate 10 mg/mL · Solution/ drops · Ophthalmic · Thea Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82584-307-02 | 82584030702 | 1 BOTTLE, DROPPER in 1 CARTON (82584-307-02) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Nov 1, 2022 · Sample package | |
| 82584-307-03 | 82584030703 | 1 BOTTLE, DROPPER in 1 CARTON (82584-307-03) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Nov 1, 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)
- Azasite
- Generic name (nonproprietary)
- azithromycin monohydrate
- Active ingredients
- Azithromycin monohydrate — 10 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Thea Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050810
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 82584-307_1e292167-581f-b1db-e063-6394a90ae8a1SPL ID 1e292167-581f-b1db-e063-6394a90ae8a1SPL set ID 0c5d6f5e-18ea-436f-8c62-bbaf66effe3dRxCUI 706868, 706872UNII JTE4MNN1MD
- Pharmacologic class
- Macrolide Antimicrobial
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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N482584030702followed by a unit qualifier and the quantityPackage 82584-0307-02. 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)
AzaSite ® is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: CDC coryneform group G Efficacy for this organism was studied in fewer than 10 infections. Haemophilus influenzae Staphylococcus aureus Streptococcus mitis group Streptococcus pneumoniae AzaSite is a macrolide antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: CDC coryneform group G, Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae. ( 1 )
Excerpt only. Read the full label for complete information.