Prescription drug · ANDA

Azithromycin NDC 71205-253

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

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-253Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0253Add 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
71205-253-30712050253307120502533030 mL in 1 BOTTLE, PLASTIC (71205-253-30)Marketed from Apr 1, 2019

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
Parenteral
Labeler
Proficient Rx LPNDC labeler code 71205
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207531
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 71205-253_55f728b3-b5c9-427f-a09a-2764663d4175SPL ID 55f728b3-b5c9-427f-a09a-2764663d4175SPL set ID b3761d39-9b79-4908-8b05-a1c91e599998RxCUI 141963UNII JTE4MNN1MDUPC 0371205253301
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N471205025330 followed by a unit qualifier and the quantity

Package 71205-0253-30. 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 for oral suspension USP is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2) ] Azithromycin for oral suspension USP is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: • Acute bacterial exacerbations of chronic bronchitis in adults ( Error! Hyperlink reference not valid. ) • Acute bacterial sinusitis in adults…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-253

What is NDC 71205-253?
71205-253 is the product NDC for Azithromycin, Azithromycin monohydrate 200 mg/5mL powder, for suspension, listed with the FDA by Proficient Rx LP. 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?
Proficient Rx LP, NDC labeler code 71205. 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 207531

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

FDA NDC Directory listings under ANDA 207531
ProductStrengthForm · routeLabelerProduct NDC
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-706
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-707
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-708
AzithromycinAzithromycin monohydrate 100 mg/5mLPowder, For suspensionOralEpic Pharma, LLC42806-147
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralEpic Pharma, LLC42806-149
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralEpic Pharma, LLC42806-150
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralEpic Pharma, LLC42806-151
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6226
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6296
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals, Inc.68071-3897
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-4773
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-4795
AzithromycinAzithromycin monohydrate 100 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-5035
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionParenteralPreferred Pharmaceuticals, Inc.68788-7549
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralProficient Rx LP71205-566
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralDirectRx72189-314

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in