Prescription drug · ANDA

Amoxicillin NDC 68071-4574

Amoxicillin 500 mg/1 · Capsule · Oral · NuCare Pharmaceuticals,Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68071-4574Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-4574Add 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
68071-4574-368071457403680714574033 CAPSULE in 1 BOTTLE (68071-4574-3)Marketed from Sep 25, 2018
68071-4574-468071457404680714574044 CAPSULE in 1 BOTTLE (68071-4574-4)Marketed from Sep 25, 2018
68071-4574-668071457406680714574066 CAPSULE in 1 BOTTLE (68071-4574-6)Marketed from Sep 25, 2018
68071-4574-8680714574086807145740818 CAPSULE in 1 BOTTLE (68071-4574-8)Marketed from Sep 25, 2018

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 — 500 mg/1
Dosage form
Capsule
Route
Oral
Labeler
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 064076
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)
Identifiers
Product ID 68071-4574_1ab537cf-02a7-f8a8-e063-6394a90ab52cSPL ID 1ab537cf-02a7-f8a8-e063-6394a90ab52cSPL set ID 76ba0f8d-4d1c-a5ff-e053-2a91aa0a7555RxCUI 308191UNII 804826J2HUUPC 0368071457469

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

N468071457403 followed by a unit qualifier and the quantity

Package 68071-4574-03. 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)

Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 – 1.5 ) In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Infections of the Ear, Nose, and Throat Amoxicillin is indicated in the treatment of …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-4574

What is NDC 68071-4574?
68071-4574 is the product NDC for Amoxicillin, Amoxicillin 500 mg/1 capsule, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 4 package NDCs, 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 064076

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

FDA NDC Directory listings under ANDA 064076
ProductStrengthForm · routeLabelerProduct NDC
AmoxicillinAmoxicillin 250 mg/1CapsuleOralBryant Ranch Prepack63629-7633
AmoxicillinAmoxicillin 500 mg/1CapsuleOralQPharma Inc42708-153
AmoxicillinAmoxicillin 500 mg/1CapsuleOralBryant Ranch Prepack63629-7585
AmoxicillinAmoxicillin 500 mg/1CapsuleOralBryant Ranch Prepack63629-7587
AmoxicillinAmoxicillin 500 mg/1CapsuleOralBryant Ranch Prepack63629-7801
AmoxicillinAmoxicillin 500 mg/1CapsuleOralBryant Ranch Prepack63629-7798
AmoxicillinAmoxicillin 500 mg/1CapsuleOralBryant Ranch Prepack63629-7802
AmoxicillinAmoxicillin 250 mg/1CapsuleOralProficient Rx LP63187-591
AmoxicillinAmoxicillin 250 mg/1CapsuleOralNorthwind Health Company, LLC82868-072
AmoxicillinAmoxicillin 250 mg/1CapsuleOralCoupler LLC67046-0127
AmoxicillinAmoxicillin 500 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4468
AmoxicillinAmoxicillin 500 mg/1CapsuleOralAsclemed USA, Inc.76420-192
AmoxicillinAmoxicillin 500 mg/1CapsuleOralCoupler LLC67046-0316
AmoxicillinAmoxicillin 500 mg/1CapsuleOralREMEDYREPACK INC.70518-2190
AmoxicillinAmoxicillin 250 mg/1CapsuleOralREMEDYREPACK INC.70518-2188
AmoxicillinAmoxicillin 500 mg/1CapsuleOralSandoz Inc0781-2613
AmoxicillinAmoxicillin 500 mg/1CapsuleOralREMEDYREPACK INC.70518-3914
AmoxicillinAmoxicillin 250 mg/1CapsuleOralSandoz Inc0781-2020
AmoxicillinAmoxicillin 500 mg/1CapsuleOralSportpharm LLC85766-292

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