What is NDC 80425-0218?

80425-0218 is the product NDC for Azithromycin Dihydrate, Azithromycin dihydrate 250 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 80425-0218

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0218Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0218Add 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
80425-0218-1	8042502180180425021801	1 BLISTER PACK in 1 BOX (80425-0218-1) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 9, 2023

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 — 250 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208250
Marketing start: Jan 9, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 80425-0218_2a9aa671-d0a1-2254-e063-6294a90a9f79SPL ID 2a9aa671-d0a1-2254-e063-6294a90a9f79SPL set ID f1752913-85ac-01fa-e053-2995a90a2bd8RxCUI 308460, 749783UNII 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

N480425021801 followed by a unit qualifier and the quantity

Package 80425-0218-01. 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 Dec 31, 2024.

Indications (excerpt from the label)

1. Indications and Usage 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 C…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0218

What is NDC 80425-0218?: 80425-0218 is the product NDC for Azithromycin Dihydrate, Azithromycin dihydrate 250 mg/1 tablet, film coated, listed with the FDA by Advanced Rx Pharmacy of Tennessee, 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?: Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 208250

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

FDA NDC Directory listings under ANDA 208250
Product	Strength	Form · route	Labeler	Product NDC
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-4527
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-4601
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	AvPAK	50268-074
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	TAGI Pharma, Inc.	51224-022
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1502
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2185
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals Inc.	68071-3715
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Precision Dose, Inc.	68094-900
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8800
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4160
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-430
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	DIRECT RX	72189-089
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-081
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-483
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-046
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-182
Azithromycin Dihydrate	Azithromycin dihydrate 250 mg/1	Tablet, Film coatedOral	Quality Care Products, LLC	83008-081