NDC codes

FDA NDC Directory
Product NDC (as listed)60687-753Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0753Add 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
60687-753-216068707532130 BLISTER PACK in 1 CARTON (60687-753-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-753-11)Marketed from Aug 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)
Azithromycin
Generic name (nonproprietary)
azithromycin
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 065399
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 60687-753_37616a61-0547-5914-e063-6294a90a2cb0SPL ID 37616a61-0547-5914-e063-6294a90a2cb0SPL set ID 6169e56c-10fb-448d-ab0f-14e54fcf2817RxCUI 248656, 308460UNII 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

N460687075321 followed by a unit qualifier and the quantity

Package 60687-0753-21. 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 tablets are 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 tablets are 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065399

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

FDA NDC Directory listings under ANDA 065399
ProductStrengthForm · routeLabelerProduct NDC
azithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7351
azithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-862
azithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4367
azithromycin dihydrateAzithromycin dihydrate 500 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0412

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