Prescription drug · ANDA

Azithromycin Dihydrate NDC 70518-4160

Azithromycin dihydrate 250 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-4160Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4160Add 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 NDC11-digit (billing)PackageCopy
70518-4160-070518416000705184160006 TABLET, FILM COATED in 1 BLISTER PACK (70518-4160-0)Marketed from Aug 15, 2024
70518-4160-1705184160017051841600130 TABLET, FILM COATED in 1 BLISTER PACK (70518-4160-1)Marketed from Aug 28, 2024
70518-4160-270518416002705184160026 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-2)Marketed from Sep 23, 2024
70518-4160-370518416003705184160031 BLISTER PACK in 1 CARTON (70518-4160-3) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 2, 2025
70518-4160-470518416004705184160042 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-4)Marketed from Sep 13, 2025
70518-4160-5705184160057051841600530 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-5)Marketed from Feb 1, 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 Dihydrate
Generic name (nonproprietary)
azithromycin dihydrate
Active ingredients
Azithromycin dihydrate — 250 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208250
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 70518-4160_5a1b9873-bcfc-8b80-e063-6394a90ae6dfSPL ID 5a1b9873-bcfc-8b80-e063-6394a90ae6dfSPL set ID f0cfda1a-910f-4764-8658-263037df5ea8RxCUI 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

N470518416000 followed by a unit qualifier and the quantity

Package 70518-4160-00. 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 .

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 70518-4160

What is NDC 70518-4160?
70518-4160 is the product NDC for Azithromycin Dihydrate, Azithromycin dihydrate 250 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 6 package NDCs, 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?
REMEDYREPACK INC., NDC labeler code 70518. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralCoupler LLC67046-160767046-1607-03
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralCoupler LLC67046-150267046-1502-03
azithromycin dihydrateAzithromycin dihydrate 600 mg/1TabletOralCoupler LLC67046-150367046-1503-03
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-880068788-8800-06
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-877368788-8773-0368788-8773-04
Azithromycin DihydrateAzithromycin dihydrate 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-420270518-4202-00
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralQuality Care Products, LLC83008-08183008-0081-06
azithromycin dihydrateAzithromycin dihydrate 250 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-043180425-0431-01
azithromycin dihydrateAzithromycin dihydrate 500 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-041280425-0412-01
Azithromycin DihydrateAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-410570518-4105-0070518-4105-0170518-4105-02

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
ProductStrengthForm · routeLabelerProduct NDC
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4527
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4601
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralAvPAK50268-074
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralTAGI Pharma, Inc.51224-022
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralCoupler LLC67046-1502
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralRedpharm Drug67296-2185
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals Inc.68071-3715
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralPrecision Dose, Inc.68094-900
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8800
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralProficient Rx LP71205-430
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralDIRECT RX72189-089
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-081
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-483
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-046
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0218
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralProficient Rx LP82804-182
Azithromycin DihydrateAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralQuality Care Products, LLC83008-081

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