Prescription drug · ANDA

Azithromycin NDC 55695-002

Azithromycin monohydrate 100 mg/5mL · Powder, For suspension · Oral · STATE HEALTH SERVICES, TEXAS DEPARTMENT OF

NDC codes

FDA NDC Directory
Product NDC (as listed)55695-002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55695-0002Add 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
55695-002-00556950002005569500020015 mL in 1 BOTTLE (55695-002-00)Marketed from Dec 28, 2010

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 — 100 mg/5mL
Dosage form
Powder, For suspension
Route
Oral
Labeler
STATE HEALTH SERVICES, TEXAS DEPARTMENT OFNDC labeler code 55695
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065246
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 55695-002_1287e725-48d5-e23e-e063-6394a90a96acSPL ID 1287e725-48d5-e23e-e063-6394a90a96acSPL set ID 2b821631-0df2-0fb2-e054-00144ff8d46cRxCUI 141963, 308459UNII JTE4MNN1MD
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

N455695000200 followed by a unit qualifier and the quantity

Package 55695-0002-00. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for oral suspension USP and other antibacterial drugs, azithromycin for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Azithromycin for oral suspension USP is a macrolide antibacterial drug indicated for the treatment of patients with mild to modera…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55695-002

What is NDC 55695-002?
55695-002 is the product NDC for Azithromycin, Azithromycin monohydrate 100 mg/5mL powder, for suspension, listed with the FDA by STATE HEALTH SERVICES, TEXAS DEPARTMENT OF. 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 monohydrate.
Who is the labeler?
STATE HEALTH SERVICES, TEXAS DEPARTMENT OF, NDC labeler code 55695. 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 065246

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

FDA NDC Directory listings under ANDA 065246
ProductStrengthForm · routeLabelerProduct NDC
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralTeva Pharmaceuticals USA, Inc.0093-2026
AzithromycinAzithromycin monohydrate 100 mg/5mLPowder, For suspensionOralTeva Pharmaceuticals USA, Inc.0093-2027
AzithromycinAzithromycin dihydrate 100 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-1868
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralSTATE HEALTH SERVICES, TEXAS DEPARTMENT OF55695-003
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralProficient Rx LP63187-093
AzithromycinAzithromycin monohydrate 100 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-1527
AzithromycinAzithromycin monohydrate 100 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-8675

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