What is NDC 0904-7350?

0904-7350 is the product NDC for azithromycin, Azithromycin dihydrate 250 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.

Major Pharmaceuticals, NDC labeler code 0904. 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 0904-7350 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7350Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7350Add 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
0904-7350-06	0090473500600904735006	50 BLISTER PACK in 1 CARTON (0904-7350-06) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 1, 2023
0904-7350-61	0090473506100904735061	100 BLISTER PACK in 1 CARTON (0904-7350-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 1, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 250 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Major PharmaceuticalsNDC labeler code 0904
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065398
Marketing start: May 1, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 0904-7350_4b1ba4ba-50d5-4bcd-bc69-9005c5dc3f8cSPL ID 4b1ba4ba-50d5-4bcd-bc69-9005c5dc3f8cSPL set ID 814abe38-da4a-48af-bf4b-2ce04a5aabd1RxCUI 248656, 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

N400904735006 followed by a unit qualifier and the quantity

Package 00904-7350-06. 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, 2026.

Indications (excerpt from the label)

Azithromycin tablet 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/to…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-7350

What is NDC 0904-7350?: 0904-7350 is the product NDC for azithromycin, Azithromycin dihydrate 250 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. It has 2 package NDCs, 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?: Major Pharmaceuticals, NDC labeler code 0904. 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 250 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0508	67046-0508-03
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

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	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	Coupler LLC	67046-0508
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