What is NDC 42291-044?

42291-044 is the product NDC for Azithromycin, Azithromycin monohydrate 600 mg/1 tablet, film coated, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. 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 42291-044 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-044Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0044Add 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
42291-044-30	4229100443042291004430	30 TABLET, FILM COATED in 1 BOTTLE (42291-044-30)Marketed from Apr 24, 2024

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 monohydrate — 600 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065218
Marketing start: Apr 24, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 42291-044_484c1370-43ba-a9a6-e063-6294a90ab468SPL ID 484c1370-43ba-a9a6-e063-6294a90ab468SPL set ID 16da30a2-d11c-7e8c-e063-6294a90a62e3RxCUI 204844UNII JTE4MNN1MD
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

N442291004430 followed by a unit qualifier and the quantity

Package 42291-0044-30. 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 Jan 13, 2026.

Indications (excerpt from the label)

Azithromycin tablets are 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. Azithromycin tablets are a macrolide antibacterial indicated for mild to moderate infections caused by designated, susceptible bacteria: Mycobacterial Infections ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.3 ) 1.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42291-044

What is NDC 42291-044?: 42291-044 is the product NDC for Azithromycin, Azithromycin monohydrate 600 mg/1 tablet, film coated, listed with the FDA by AvKARE. 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 monohydrate.
Who is the labeler?: AvKARE, NDC labeler code 42291. 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 065218

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

FDA NDC Directory listings under ANDA 065218
Product	Strength	Form · route	Labeler	Product NDC
Azithromycin	Azithromycin monohydrate 600 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	50111-789