NDC codes

FDA NDC Directory
Product NDC (as listed)72189-088Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0088Add 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
72189-088-02721890088022 TABLET, FILM COATED in 1 BOTTLE (72189-088-02)Marketed from Jun 18, 2020
72189-088-03721890088033 TABLET, FILM COATED in 1 BOTTLE (72189-088-03)Marketed from Jun 18, 2020

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
Labeler
DIRECT RX
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210001
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 72189-088_4d3a98e6-31e9-c271-e063-6394a90aa19eSPL ID 4d3a98e6-31e9-c271-e063-6394a90aa19eSPL set ID a5b4092d-ab72-f5d1-e053-2995a90ac582RxCUI 248656, 308460, 749780, 749783UNII 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

N472189008802 followed by a unit qualifier and the quantity

Package 72189-0088-02. 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 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 pneumo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210001

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

FDA NDC Directory listings under ANDA 210001
ProductStrengthForm · routeLabelerProduct NDC
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralAvKARE42291-083
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2297
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralProficient Rx LP71205-503
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralBionpharma Inc.69452-172
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1755

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