Prescription drug · ANDA

Azithromycin NDC 63187-093

Azithromycin monohydrate 200 mg/5mL · Powder, For suspension · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-093Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0093Add 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
63187-093-15631870093156318700931515 mL in 1 BOTTLE (63187-093-15)Marketed from Jul 1, 2014
63187-093-22631870093226318700932222.5 mL in 1 BOTTLE (63187-093-22)Marketed from Apr 3, 2024
63187-093-30631870093306318700933030 mL in 1 BOTTLE (63187-093-30)Marketed from Jul 1, 2014

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 — 200 mg/5mL
Dosage form
Powder, For suspension
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
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 63187-093_9d10dacc-ad17-48ec-b037-94987b2c40bcSPL ID 9d10dacc-ad17-48ec-b037-94987b2c40bcSPL set ID 44134421-cb0b-4e85-a3c8-d58bdb476fadRxCUI 141963UNII JTE4MNN1MDUPC 0363187093150
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

N463187009315 followed by a unit qualifier and the quantity

Package 63187-0093-15. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Azithromycin for oral suspension USP is indicated for the treatment of patients with mild to moderate infections (pneumonia: see WARNINGS ) caused by susceptible strains of the designated microorganisms in the specific conditions listed below. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, please see DOSAGE AND ADMINISTRATION for specific dosing recommendations. Adults Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptoco…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-093

What is NDC 63187-093?
63187-093 is the product NDC for Azithromycin, Azithromycin monohydrate 200 mg/5mL powder, for suspension, listed with the FDA by Proficient Rx LP. 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?
Proficient Rx LP, NDC labeler code 63187. 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 100 mg/5mLPowder, For suspensionOralSTATE HEALTH SERVICES, TEXAS DEPARTMENT OF55695-002
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralSTATE HEALTH SERVICES, TEXAS DEPARTMENT OF55695-003
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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