Azithromycin NDC 63187-093

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-093Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0093Add 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
63187-093-15	63187009315	15 mL in 1 BOTTLE (63187-093-15)Marketed from Jul 1, 2014
63187-093-22	63187009322	22.5 mL in 1 BOTTLE (63187-093-22)Marketed from Apr 3, 2024
63187-093-30	63187009330	30 mL in 1 BOTTLE (63187-093-30)Marketed from Jul 1, 2014

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 monohydrate — 200 mg/5mL
Dosage form: Powder, For suspension
Route: Oral
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065246
Marketing start: Dec 17, 2010
Listing expires: Dec 31, 2026
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 63187-093_9d10dacc-ad17-48ec-b037-94987b2c40bcSPL ID 9d10dacc-ad17-48ec-b037-94987b2c40bcSPL set ID 44134421-cb0b-4e85-a3c8-d58bdb476fadRxCUI 141963UNII JTE4MNN1MDUPC 0363187093150
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

N463187009315 followed by a unit qualifier and the quantity

Package 63187-0093-15. 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 Apr 1, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Azithromycin for oral suspension USP is indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS ) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations. Adults Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptoco…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065246

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

FDA NDC Directory listings under ANDA 065246
Product	Strength	Form · route	Labeler	Product NDC
Azithromycin	Azithromycin dihydrate 100 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-1868
Azithromycin	Azithromycin monohydrate 200 mg/5mL	Powder, For suspensionOral	Teva Pharmaceuticals USA, Inc.	0093-2026
Azithromycin	Azithromycin monohydrate 100 mg/5mL	Powder, For suspensionOral	Teva Pharmaceuticals USA, Inc.	0093-2027
Azithromycin	Azithromycin monohydrate 100 mg/5mL	Powder, For suspensionOral	Preferred Pharmaceuticals Inc.	68788-8675
Azithromycin	Azithromycin monohydrate 100 mg/5mL	Powder, For suspensionOral	STATE HEALTH SERVICES, TEXAS DEPARTMENT OF	55695-002
Azithromycin	Azithromycin monohydrate 200 mg/5mL	Powder, For suspensionOral	STATE HEALTH SERVICES, TEXAS DEPARTMENT OF	55695-003
Azithromycin	Azithromycin monohydrate 100 mg/5mL	Powder, For suspensionOral	NuCare Pharmaceuticals,Inc.	68071-1527