Azithromycin monohydrate NDC 68083-199

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-199Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0199Add 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 NDC	11-digit (billing)	Package	Copy
68083-199-10	68083019910	10 VIAL in 1 CARTON (68083-199-10) / 10 mL in 1 VIALMarketed from Nov 9, 2009

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 monohydrate
Generic name (nonproprietary): azithromycin monohydrate
Active ingredients: Azithromycin monohydrate — 500 mg/10mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065501
Marketing start: Nov 9, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 68083-199_87bbc473-3fe8-475b-bf73-2e101377977aSPL ID 87bbc473-3fe8-475b-bf73-2e101377977aSPL set ID 55051e03-b6dc-4bc6-87c1-e4fb84b61fa3RxCUI 1668238UNII JTE4MNN1MDUPC 0368083199104
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468083019910 followed by a unit qualifier and the quantity

Package 68083-0199-10. 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 Aug 12, 2026.

Indications (excerpt from the label)

Azithromycin for injection is a macrolide antibacterial drug indicated for the treatment of the following infections caused by designated susceptible microorganisms: • Community-acquired pneumonia in adults ( 1.1 ) • Pelvic inflammatory disease in adults ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.3 ) 1.1 Community-Acquired Pneumonia Azithromycin for injection is indicated for the treatment of adult patients with community-acquired pneumonia due to the foll…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065501

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

FDA NDC Directory listings under ANDA 065501
Product	Strength	Form · route	Labeler	Product NDC
Azithromycinazithromycin monohydrate	Azithromycin monohydrate 500 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Athenex Pharmaceutical Division, LLC.	70860-100
Azithromycinazithromycin monohydrate	Azithromycin monohydrate 500 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Athenex Pharmaceutical Division, LLC.	70860-125
Azithromycin monohydrate	Azithromycin monohydrate 500 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sun Pharmaceutical Industries Limited	70095-025
Azithromycinazithromycin monohydrate	Azithromycin monohydrate 500 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-180
Azithromycinazithromycin monohydrate	Azithromycin monohydrate 500 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-180