Prescription drug · ANDA

Azithromycin NDC 70518-2433

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

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-2433Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-2433Add 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
70518-2433-0705182433007051824330030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2433-0)Marketed from Nov 19, 2019
70518-2433-270518243302705182433026 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2433-2)Marketed from Jan 28, 2020

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 — 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 207370
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 70518-2433_5d1c4719-426c-0090-e063-6294a90a510dSPL ID 5d1c4719-426c-0090-e063-6294a90a510d
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

N470518243300 followed by a unit qualifier and the quantity

Package 70518-2433-00. 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

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

About NDC 70518-2433

What is NDC 70518-2433?
70518-2433 is the product NDC for Azithromycin, Azithromycin dihydrate 250 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 2 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 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 207370

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

FDA NDC Directory listings under ANDA 207370
ProductStrengthForm · routeLabelerProduct NDC
AzithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4720
AzithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4721
AzithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7550
AzithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8012
AzithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4812
AzithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4902
AzithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8702
AzithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralProficient Rx LP71205-158
AzithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2668
AzithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralDIRECT RX72189-087

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