NDC codes

FDA NDC Directory
Product NDC (as listed)42708-010Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42708-0010Add 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
42708-010-30427080010304270800103030 CAPSULE in 1 BOTTLE (42708-010-30)Marketed from Mar 1, 2018 · Sample package

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)
Amoxicillin
Generic name (nonproprietary)
amoxicillin
Active ingredients
Amoxicillin — 500 mg/1
Dosage form
Capsule
Route
Oral
Labeler
QPharma, IncNDC labeler code 42708
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 061926
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)
Identifiers
Product ID 42708-010_5153c0f3-8cbe-a0fe-e063-6294a90a5d39SPL ID 5153c0f3-8cbe-a0fe-e063-6294a90a5d39SPL set ID 60c788d1-6c91-4456-848a-893e649e90beRxCUI 308191UNII 804826J2HU

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

N442708001030 followed by a unit qualifier and the quantity

Package 42708-0010-30. 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)

Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of E…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42708-010

What is NDC 42708-010?
42708-010 is the product NDC for Amoxicillin, Amoxicillin 500 mg/1 capsule, listed with the FDA by QPharma, 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?
QPharma, Inc, NDC labeler code 42708. 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 061926

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

FDA NDC Directory listings under ANDA 061926
ProductStrengthForm · routeLabelerProduct NDC
AmoxicillinAmoxicillin 250 mg/1CapsuleOralRedpharm Drug67296-0002
AmoxicillinAmoxicillin 250 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4944
AmoxicillinAmoxicillin 500 mg/1CapsuleOralChartwell Governmental & Specialty RX, LLC68999-112
AmoxicillinAmoxicillin 250 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3107
AmoxicillinAmoxicillin 500 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0093-3109
AmoxicillinAmoxicillin 500 mg/1CapsuleOralAsclemed USA, Inc.76420-545
AmoxicillinAmoxicillin 250 mg/1CapsuleOralNorthwind Health Company, LLC82868-088
AmoxicillinAmoxicillin 500 mg/1CapsuleOralREMEDYREPACK INC.70518-3234
AmoxicillinAmoxicillin 250 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4741
AmoxicillinAmoxicillin 250 mg/1CapsuleOralChartwell RX, LLC62135-111
AmoxicillinAmoxicillin 500 mg/1CapsuleOralChartwell RX, LLC62135-112
AmoxicillinAmoxicillin 500 mg/1CapsuleOralSportpharm LLC85766-293

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