NDC codes

FDA NDC Directory
Product NDC (as listed)70518-4367Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4367Add 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
70518-4367-0705184367007051843670030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4367-0)Marketed from Jun 20, 2025
70518-4367-170518436701705184367012 POUCH in 1 BOX (70518-4367-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-4367-2)Marketed from Jun 25, 2025
70518-4367-370518436703705184367032 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4367-3)Marketed from Sep 26, 2025
70518-4367-470518436704705184367045 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4367-4)Marketed from Sep 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
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 065399
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 70518-4367_5a7f288b-4e9c-15e9-e063-6294a90a949bSPL ID 5a7f288b-4e9c-15e9-e063-6294a90a949bSPL set ID bf061799-cdef-40f8-b1ce-bc5eb609f8c3RxCUI 248656UNII 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

N470518436700 followed by a unit qualifier and the quantity

Package 70518-4367-00. 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 tablets are 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 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/tonsillitis in adults and pediatric patients (2 years of age and older) ( 1.1 , 1.2 ) Limitation of Use…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-4367

What is NDC 70518-4367?
70518-4367 is the product NDC for azithromycin, Azithromycin dihydrate 500 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 4 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?
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 250 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-435670518-4356-00
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-70724658-0707-33

All 147 azithromycin NDCs

Other NDCs under ANDA 065399

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

FDA NDC Directory listings under ANDA 065399
ProductStrengthForm · routeLabelerProduct NDC
azithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7351
AzithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-753
azithromycinAzithromycin dihydrate 500 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-862
azithromycin dihydrateAzithromycin dihydrate 500 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0412

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