Prescription drug · ANDA

Amoxicillin NDC 68071-1761

Amoxicillin 125 mg/5mL · Powder, For suspension · Oral · NuCare Pharmaceuticals,Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68071-1761Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-1761Add 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
68071-1761-56807117610568071176105150 mL in 1 BOTTLE (68071-1761-5)Marketed from Oct 25, 2017

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)
Amoxicillin
Generic name (nonproprietary)
amoxicillin
Active ingredients
Amoxicillin — 125 mg/5mL
Dosage form
Powder, For suspension
Route
Oral
Labeler
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065322
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)
Identifiers
Product ID 68071-1761_2a488ba2-1b76-9dd8-e063-6394a90aa946SPL ID 2a488ba2-1b76-9dd8-e063-6394a90aa946SPL set ID 5c60cb1c-3baf-3af2-e053-2a91aa0ae208RxCUI 313797UNII 804826J2HUUPC 0368071176155

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

N468071176105 followed by a unit qualifier and the quantity

Package 68071-1761-05. 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 Amoxicillin and other antibacterial drugs, Amoxicillin for Oral Suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by 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. Amoxicillin for Oral Suspension, USP is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-1761

What is NDC 68071-1761?
68071-1761 is the product NDC for Amoxicillin, Amoxicillin 125 mg/5mL powder, for suspension, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Amoxicillin.
What is the active ingredient?
Amoxicillin.
Who is the labeler?
NuCare Pharmaceuticals,Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amoxicillin?
274 other product NDCs are listed under this name. See all Amoxicillin 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 Amoxicillin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AmoxicillinAmoxicillin 250 mg/1CapsuleOralNorthwind Health Company, LLC82868-08882868-0088-30
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralCoupler LLC67046-073467046-0734-03
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-415268788-4152-02
AmoxicillinAmoxicillin 500 mg/1CapsuleOralCoupler LLC67046-031667046-0316-03
AmoxicillinAmoxicillin 250 mg/1CapsuleOralCoupler LLC67046-012767046-0127-03
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralCoupler LLC67046-001567046-0015-03
AmoxicillinAmoxicillin 500 mg/1CapsuleOralCoupler LLC67046-117567046-1175-03
AmoxicillinAmoxicillin 875 mg/1Tablet, CoatedOralPreferred Pharmaceuticals Inc.68788-406268788-4062-02
AmoxicillinAmoxicillin 400 mg/5mLFor suspensionOralREMEDYREPACK INC.70518-452970518-4529-00
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralREMEDYREPACK INC.70518-452270518-4522-00

All 275 Amoxicillin NDCs

Other NDCs under ANDA 065322

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

FDA NDC Directory listings under ANDA 065322
ProductStrengthForm · routeLabelerProduct NDC
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralProficient Rx LP63187-029
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-0406
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-0404
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-0405
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-0411
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-0407
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-8759
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-1760
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralHikma Pharmaceuticals USA Inc.0143-9888
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralHikma Pharmaceuticals USA Inc.0143-9889
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.66267-993
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralProficient Rx LP63187-295
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-2251
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-4024
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals Inc.68071-3678
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-2364

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