What is NDC 67046-1607?

67046-1607 is the product NDC for Azithromycin Dihydrate, Azithromycin dihydrate 500 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Coupler LLC, NDC labeler code 67046. 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 67046-1607

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-1607Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-1607Add 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
67046-1607-3	6704616070367046160703	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1607-3)Marketed from Oct 20, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Coupler LLCNDC labeler code 67046
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208249
Marketing start: Oct 20, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 67046-1607_4196de9a-0c36-7cfe-e063-6394a90a409aSPL ID 4196de9a-0c36-7cfe-e063-6394a90a409aSPL set ID 4196e616-bdd8-9e88-e063-6394a90ac81dRxCUI 248656UNII 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

N467046160703 followed by a unit qualifier and the quantity

Package 67046-1607-03. 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 Oct 20, 2025.

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) ] Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-1607

What is NDC 67046-1607?: 67046-1607 is the product NDC for Azithromycin Dihydrate, Azithromycin dihydrate 500 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, 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?: Coupler LLC, NDC labeler code 67046. 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 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
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4105	70518-4105-0070518-4105-0170518-4105-02

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	REMEDYREPACK INC.	70518-4105
Azithromycin Dihydrate	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-491