What is NDC 72189-090?

72189-090 is the product NDC for Azithromycin Dihydrate, Azithromycin dihydrate 500 mg/1 tablet, film coated, listed with the FDA by DIRECT RX. It has 2 package NDCs, shown above in 10- and 11-digit form.

DIRECT RX, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Azithromycin Dihydrate?

42 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Azithromycin Dihydrate NDC 72189-090

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-090Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0090Add 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
72189-090-02	7218900900272189009002	2 TABLET, FILM COATED in 1 BOX (72189-090-02)Marketed from May 22, 2020
72189-090-03	7218900900372189009003	3 TABLET, FILM COATED in 1 BOX (72189-090-03)Marketed from May 22, 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 Dihydrate
Generic name (nonproprietary): azithromycin dihydrate
Active ingredients: Azithromycin dihydrate — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: DIRECT RXNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208249
Marketing start: May 22, 2020
Marketing end: Oct 31, 2026
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 72189-090_4d3a97f3-7ddd-c49d-e063-6394a90a84eaSPL ID 4d3a97f3-7ddd-c49d-e063-6394a90a84eaSPL set ID a6426d5f-5518-3c69-e053-2995a90af50fRxCUI 248656, 749780UNII 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

N472189009002 followed by a unit qualifier and the quantity

Package 72189-0090-02. 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 Mar 17, 2026.

Indications (excerpt from the label)

Azithromycin is 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)] 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 pneumoniae, …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-090

What is NDC 72189-090?: 72189-090 is the product NDC for Azithromycin Dihydrate, Azithromycin dihydrate 500 mg/1 tablet, film coated, listed with the FDA by DIRECT RX. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Azithromycin Dihydrate.
What is the active ingredient?: Azithromycin dihydrate.
Who is the labeler?: DIRECT RX, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Azithromycin Dihydrate?: 42 other product NDCs are listed under this name. See all Azithromycin Dihydrate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Azithromycin Dihydrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1607	67046-1607-03
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1502	67046-1502-03
azithromycin dihydrate	Azithromycin dihydrate 600 mg/1	TabletOral	Coupler LLC	67046-1503	67046-1503-03
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8800	68788-8800-06
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8773	68788-8773-0368788-8773-04
Azithromycin Dihydrate	Azithromycin dihydrate 600 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4202	70518-4202-00
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Quality Care Products, LLC	83008-081	83008-0081-06
azithromycin dihydrate	Azithromycin dihydrate 250 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0431	80425-0431-01
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4160	70518-4160-0070518-4160-0170518-4160-02+3 more
azithromycin dihydrate	Azithromycin dihydrate 500 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0412	80425-0412-01

All 43 Azithromycin Dihydrate NDCs

Other NDCs under ANDA 208249

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

FDA NDC Directory listings under ANDA 208249
Product	Strength	Form · route	Labeler	Product NDC
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8773
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-1942
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-4700
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Precision Dose, Inc.	68094-799
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2581
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0220
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Health Department, Oklahoma State	83112-501
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3661
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Sportpharm LLC	85766-042
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7506
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-153
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-445
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7299
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7298
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1607
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4105
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-491