NDC codes

FDA NDC Directory
Product NDC (as listed)68788-7598Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7598Add 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
68788-7598-368788759803687887598033 TABLET, FILM COATED in 1 BLISTER PACK (68788-7598-3)Marketed from Feb 13, 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 — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
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 68788-7598_6efa1622-de6a-4eee-b5bb-6a8149bbe1c1SPL ID 6efa1622-de6a-4eee-b5bb-6a8149bbe1c1SPL set ID 003307c5-3f73-4a5d-a704-bfdea3c656e8RxCUI 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

N468788759803 followed by a unit qualifier and the quantity

Package 68788-7598-03. 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 () • Acute bacterial sinusitis in adults () • Uncomplicated skin and skin structure infections in adults () • Urethritis and ce…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-7598

What is NDC 68788-7598?
68788-7598 is the product NDC for Azithromycin, Azithromycin dihydrate 500 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 coatedOralREMEDYREPACK INC.70518-3508
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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