What is NDC 67046-0508?

67046-0508 is the product NDC for azithromycin, Azithromycin dihydrate 250 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?

146 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

azithromycin NDC 67046-0508 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67046-0508Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67046-0508Add 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
67046-0508-3	6704605080367046050803	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0508-3)Marketed from May 4, 2026

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
Generic name (nonproprietary): azithromycin
Active ingredients: Azithromycin dihydrate — 250 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 065398
Marketing start: May 4, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 67046-0508_510024c9-6616-e08f-e063-6294a90a0793SPL ID 510024c9-6616-e08f-e063-6294a90a0793SPL set ID 510024c9-6658-e08f-e063-6294a90a0793RxCUI 308460UNII 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

N467046050803 followed by a unit qualifier and the quantity

Package 67046-0508-03. 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 May 4, 2026.

Indications (excerpt from the label)

Azithromycin tablets are 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 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/tonsillitis in adults and pediatric patients (2 years of age and older) ( 1.1 , 1.2 ) Limitation of Use…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67046-0508

What is NDC 67046-0508?: 67046-0508 is the product NDC for azithromycin, Azithromycin dihydrate 250 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.
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?: 146 other product NDCs are listed under this name. See all azithromycin 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1698	67046-1698-03
azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-726	64980-0726-0364980-0726-13
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-727	64980-0727-0364980-0727-16
Azithromycin	Azithromycin dihydrate 200 mg/5mL	Powder, For suspensionOral	AiPing Pharmaceutical, Inc.	11788-129	11788-0129-1311788-0129-1411788-0129-15
Azithromycin	Azithromycin dihydrate 100 mg/5mL	Powder, For suspensionOral	AiPing Pharmaceutical, Inc.	11788-128	11788-0128-13
Azithromycin	Azithromycin dihydrate 200 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-8144	50090-8144-00
Azithromycinazithromycin monohydrate	Azithromycin monohydrate 500 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-180	25021-0180-10
azithromycin	Azithromycin dihydrate 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4367	70518-4367-0070518-4367-0170518-4367-03+1 more
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4356	70518-4356-00
Azithromycin	Azithromycin monohydrate 200 mg/5mL	Powder, For suspensionOral	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	24658-707	24658-0707-33

All 147 azithromycin NDCs

Other NDCs under ANDA 065398

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

FDA NDC Directory listings under ANDA 065398
Product	Strength	Form · route	Labeler	Product NDC
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7350
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-3374
Azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-742
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-861
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4356
azithromycin	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-214
azithromycin dihydrate	Azithromycin dihydrate 250 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0431