Prescription drug · ANDA

Azithromycin NDC 68071-4795

Azithromycin monohydrate 200 mg/5mL · Powder, For suspension · Oral · NuCare Pharmaceuticals,Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68071-4795Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-4795Add 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
68071-4795-36807147950330 mL in 1 BOX (68071-4795-3)Marketed from Mar 7, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
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 68071-4795_1adc57cf-712e-75b9-e063-6294a90a0de0SPL ID 1adc57cf-712e-75b9-e063-6294a90a0de0SPL set ID 8389c336-25eb-a96f-e053-2a91aa0a0dd8RxCUI 141963UNII JTE4MNN1MDUPC 0368071479539
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

N468071479503 followed by a unit qualifier and the quantity

Package 68071-4795-03. 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 ( 1.1 ) Acute bacterial sinusitis in adults ( 1.1 ) Uncomplicated skin and skin s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 suspensionOralNuCare Pharmaceuticals, Inc.68071-3897
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-4773
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionParenteralPreferred Pharmaceuticals, Inc.68788-7549
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 200 mg/5mLPowder, For suspensionOralDirectRx72189-314
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6226
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralEpic Pharma, LLC42806-149
AzithromycinAzithromycin monohydrate 100 mg/5mLPowder, For suspensionOralEpic Pharma, LLC42806-147
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 suspensionParenteralProficient Rx LP71205-253
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6296
AzithromycinAzithromycin monohydrate 200 mg/5mLPowder, For suspensionOralProficient Rx LP71205-566
AzithromycinAzithromycin monohydrate 100 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-5035

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