Prescription drug · ANDA

Azithromycin NDC 70518-3508

Azithromycin dihydrate 500 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-3508Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-3508Add 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
70518-3508-2705183508027051835080230 TABLET, FILM COATED in 1 BLISTER PACK (70518-3508-2)Marketed from Sep 21, 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 — 500 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 207398
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 70518-3508_5c0047b4-1e9f-f940-e063-6394a90a8c64SPL ID 5c0047b4-1e9f-f940-e063-6394a90a8c64
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

N470518350802 followed by a unit qualifier and the quantity

Package 70518-3508-02. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 70518-3508

What is NDC 70518-3508?
70518-3508 is the product NDC for Azithromycin, Azithromycin dihydrate 500 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. 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?
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?
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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralCoupler LLC67046-169867046-1698-03
azithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.64980-72664980-0726-0364980-0726-13
azithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.64980-72764980-0727-0364980-0727-16
azithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralCoupler LLC67046-050867046-0508-03
AzithromycinAzithromycin dihydrate 200 mg/5mLPowder, For suspensionOralAiPing Pharmaceutical, Inc.11788-12911788-0129-1311788-0129-1411788-0129-15
AzithromycinAzithromycin dihydrate 100 mg/5mLPowder, For suspensionOralAiPing Pharmaceutical, Inc.11788-12811788-0128-13
AzithromycinAzithromycin dihydrate 200 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-814450090-8144-00
Azithromycinazithromycin monohydrateAzithromycin monohydrate 500 mg/5mLInjection, Powder, Lyophilized, For solutionIntravenousSagent Pharmaceuticals25021-18025021-0180-10
azithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-436770518-4367-0070518-4367-0170518-4367-03+1 more
azithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-435670518-4356-00

All 147 Azithromycin NDCs

Other NDCs under ANDA 207398

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

FDA NDC Directory listings under ANDA 207398
ProductStrengthForm · routeLabelerProduct NDC
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5366
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5376
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8013
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8017
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-8251
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-642
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralRedpharm Drug67296-1945
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4976
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5058
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5082
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7598
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralProficient Rx LP71205-519
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2669
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralDirect_Rx72189-015

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