Prescription drug · ANDA

Azithromycin Dihydrate NDC 83112-501

Azithromycin dihydrate 500 mg/1 · Tablet, Film coated · Oral · Health Department, Oklahoma State

NDC codes

FDA NDC Directory
Product NDC (as listed)83112-501Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83112-0501Add 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
83112-501-00831120501002 TABLET, FILM COATED in 1 PACKET (83112-501-00)Marketed from Feb 15, 2024
83112-501-02831120501022 TABLET, FILM COATED in 1 PACKET (83112-501-02)Marketed from Feb 15, 2024
83112-501-04831120501044 TABLET, FILM COATED in 1 PACKET (83112-501-04)Marketed 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 83112-501_4747c5d8-4832-c725-e063-6394a90a4fdaSPL ID 4747c5d8-4832-c725-e063-6394a90a4fdaSPL set ID 4747c5d8-4831-c725-e063-6394a90a4fdaRxCUI 248656UNII 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

N483112050100 followed by a unit qualifier and the quantity

Package 83112-0501-00. 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)] 1.1 Adult Patients Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis. or Streptococcus pneumoniae. Community-acquired pneumonia due to Chlamydophila pneumoniae, …

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 coatedOralSportpharm LLC85766-042
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 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

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