Prescription drug · ANDA

Azithromycin Dihydrate NDC 85766-042

Azithromycin dihydrate 500 mg/1 · Tablet, Film coated · Oral · Sportpharm LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)85766-042Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85766-0042Add 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
85766-042-03857660042031 BLISTER PACK in 1 CARTON (85766-042-03) / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 7, 2025
85766-042-09857660042093 CARTON in 1 BOX (85766-042-09) / 1 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 15, 2024

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)
Azithromycin Dihydrate
Generic name (nonproprietary)
azithromycin dihydrate
Active ingredients
Azithromycin dihydrate — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208249
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 85766-042_4a2bff9c-8890-4ac6-e063-6294a90ad59fSPL ID 4a2bff9c-8890-4ac6-e063-6294a90ad59fSPL set ID 11446677-a3dc-40cb-897d-7a9851b8c89cRxCUI 248656, 749780UNII 5FD1131I7S
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N485766004203 followed by a unit qualifier and the quantity

Package 85766-0042-03. 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)

Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2) ] Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1 ) Acute bacterial sinusitis in adults ( 1.1 ) Uncomplicated skin and skin structure infections in adults ( 1.1 ) Urethritis…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208249

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208249
ProductStrengthForm · routeLabelerProduct NDC
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8773
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralDIRECT RX72189-090
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0220
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3168
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3661
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4700
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralTAGI Pharma, Inc.51224-122
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralProficient Rx LP82804-153
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7506
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralCoupler LLC67046-1607
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralProficient Rx LP71205-491
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4105
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-445
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralHealth Department, Oklahoma State83112-501
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7299
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7298
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2581
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralPrecision Dose, Inc.68094-799
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralRedpharm Drug67296-1942

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in