NDC codes

FDA NDC Directory
Product NDC (as listed)0781-8089Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-8089Add 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
0781-8089-2600781808926007818089266 DOSE PACK in 1 CARTON (0781-8089-26) / 1 TABLET, FILM COATED in 1 DOSE PACKMarketed from Feb 14, 2019
0781-8089-31007818089310078180893130 TABLET, FILM COATED in 1 BOTTLE (0781-8089-31)Marketed from Feb 14, 2019
0781-8089-6900781808969007818089695 BLISTER PACK in 1 CARTON (0781-8089-69) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 14, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Sandoz IncNDC labeler code 0781
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065211
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 0781-8089_fd0d853c-9304-4e6e-be78-74166dbb8126SPL ID fd0d853c-9304-4e6e-be78-74166dbb8126SPL set ID ec619299-e0ef-44dd-acdb-8c53bbfc5b8aRxCUI 248656, 308460, 749780, 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

N400781808926 followed by a unit qualifier and the quantity

Package 00781-8089-26. 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 treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: • 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/…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-8089

What is NDC 0781-8089?
0781-8089 is the product NDC for Azithromycin, Azithromycin dihydrate 250 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 3 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?
Sandoz Inc, NDC labeler code 0781. 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 065211

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

FDA NDC Directory listings under ANDA 065211
ProductStrengthForm · routeLabelerProduct NDC
AzithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8124
AzithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralProficient Rx LP71205-645
AzithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-213
AzithromycinAzithromycin dihydrate 250 mg/1Tablet, Film coatedOralSportpharm LLC85766-008

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