NDC codes

FDA NDC Directory
Product NDC (as listed)0781-8091Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-8091Add 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
0781-8091-310078180913130 TABLET, FILM COATED in 1 BOTTLE (0781-8091-31)Marketed 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 — 600 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 065209
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 0781-8091_2c6bb78a-a9da-43e0-9a72-b8723229e1b7SPL ID 2c6bb78a-a9da-43e0-9a72-b8723229e1b7SPL set ID 34b70c23-92a6-460f-8dbb-15a0e6b9d3a9RxCUI 204844UNII 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

N400781809131 followed by a unit qualifier and the quantity

Package 00781-8091-31. 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 indicated for the treatment of adult patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: • Sexually Transmitted Diseases ( 1.1 ) • Mycobacterial Infections ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.3 ) 1.1 Sexually Transmitted Diseases Azithromycin tablets are indicated for the treatment of adult patients with mild to mod…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-8091

What is NDC 0781-8091?
0781-8091 is the product NDC for Azithromycin, Azithromycin dihydrate 600 mg/1 tablet, film coated, listed with the FDA by Sandoz 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?
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?
139 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 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 100 mg/5mLPowder, For suspensionOralAiPing Pharmaceutical, Inc.11788-12811788-0128-13
AzithromycinAzithromycin dihydrate 200 mg/5mLPowder, For suspensionOralAiPing Pharmaceutical, Inc.11788-12911788-0129-1311788-0129-1411788-0129-15
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
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-70724658-0707-33
AzithromycinAzithromycin dihydrate 200 mg/5mLPowder, For suspensionOralZhejiang Poly Pharm. Co., Ltd.72673-08172673-0081-60
AzithromycinAzithromycin dihydrate 200 mg/5mLPowder, For suspensionOralZhejiang Poly Pharm. Co., Ltd.72673-08272673-0082-90

All 140 Azithromycin NDCs

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