NDC codes

FDA NDC Directory
Product NDC (as listed)59651-008Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0008Add 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
59651-008-15596510008151 BOTTLE in 1 CARTON (59651-008-15) / 15 mL in 1 BOTTLEMarketed from Oct 9, 2018
59651-008-23596510008231 BOTTLE in 1 CARTON (59651-008-23) / 22.5 mL in 1 BOTTLEMarketed from Oct 9, 2018
59651-008-30596510008301 BOTTLE in 1 CARTON (59651-008-30) / 30 mL in 1 BOTTLEMarketed from Oct 9, 2018

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 — 200 mg/5mL
Dosage form
Powder, For suspension
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209201
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 59651-008_a64d5e91-7ab9-4fdc-93d6-7c96878c6fc5SPL ID a64d5e91-7ab9-4fdc-93d6-7c96878c6fc5SPL set ID 3c902990-b870-4725-b9fe-76b8be633e1cRxCUI 141963, 308459UNII 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

N459651000815 followed by a unit qualifier and the quantity

Package 59651-0008-15. 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 .

Indications (excerpt from the label)

Azithromycin for oral suspension is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 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 and cervicitis in adults ( 1.1 ) Genital ulcer disease in men ( 1.1 ) Acute otitis media in pediatric patients (6 months of age and older) ( 1.2 ) Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1.1 , 1.2 ) Pharyngitis/tonsi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209201

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

FDA NDC Directory listings under ANDA 209201
ProductStrengthForm · routeLabelerProduct NDC
AzithromycinAzithromycin dihydrate 100 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited59651-007

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