NDC codes

FDA NDC Directory
Product NDC (as listed)50111-787Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50111-0787Add 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
50111-787-10501110787105011107871030 TABLET, FILM COATED in 1 BOTTLE (50111-787-10)Marketed from Jan 6, 2006
50111-787-5150111078751501110787511 BLISTER PACK in 1 CARTON (50111-787-51) / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 6, 2006
50111-787-6650111078766501110787663 CARTON in 1 PACKAGE (50111-787-66) / 1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 6, 2006

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 monohydrate — 250 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Teva Pharmaceuticals USA, Inc.NDC labeler code 50111
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065225
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 50111-787_96661456-78d1-48f2-bcd9-ceb3a8437387SPL ID 96661456-78d1-48f2-bcd9-ceb3a8437387SPL set ID f6a52c0b-45db-422e-8c22-e867a11b4439RxCUI 248656, 308460, 749780, 749783UNII JTE4MNN1MDUPC 0350111788107, 0350111787100
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

N450111078710 followed by a unit qualifier and the quantity

Package 50111-0787-10. 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/tonsillitis in a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50111-787

What is NDC 50111-787?
50111-787 is the product NDC for Azithromycin, Azithromycin monohydrate 250 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals USA, 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 monohydrate.
Who is the labeler?
Teva Pharmaceuticals USA, Inc., NDC labeler code 50111. 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 065225

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

FDA NDC Directory listings under ANDA 065225
ProductStrengthForm · routeLabelerProduct NDC
Azithromycinazithromycin monohydrateAzithromycin monohydrate 500 mg/1Tablet, Film coatedOralPharmPak, Inc.54348-857
AzithromycinAzithromycin monohydrate 250 mg/1Tablet, Film coatedOralProficient Rx LP63187-007
AzithromycinAzithromycin monohydrate 250 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0784
AzithromycinAzithromycin monohydrate 250 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-006
AzithromycinAzithromycin monohydrate 250 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0219
AzithromycinAzithromycin monohydrate 250 mg/1Tablet, Film coatedOralSportpharm LLC85766-007

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