NDC codes

FDA NDC Directory
Product NDC (as listed)67296-1921Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67296-1921Add 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
67296-1921-7672961921076729619210775 mL in 1 BOTTLE (67296-1921-7)Marketed from Sep 19, 2022

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

Generic name (nonproprietary)
amoxicillin and clavulanate potassium
Active ingredients
Amoxicillin — 600 mg/5mLClavulanate potassium — 42.9 mg/5mL
Dosage form
For suspension
Route
Oral
Labeler
Redpharm DrugNDC labeler code 67296
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 050755
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers
Product ID 67296-1921_4727cd5c-c786-7e6f-e063-6294a90a57eaSPL ID 4727cd5c-c786-7e6f-e063-6294a90a57eaSPL set ID 2fbb57ba-08d8-0224-e063-6294a90ab683RxCUI 617993UNII 804826J2HU, Q42OMW3AT8UPC 0381964203691, 0381964203547
Pharmacologic class
Penicillin-class Antibacterial; beta Lactamase Inhibitor

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

N467296192107 followed by a unit qualifier and the quantity

Package 67296-1921-07. 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 and Clavulanate Potassium is indicated for the treatment of pediatric patients with Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains) characterized by the following risk factors: - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) daycare attendance [see Microbiology ( 12.4 )] Limitations of Use Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Amoxicillin and Clavulanate Potassium…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67296-1921

What is NDC 67296-1921?
67296-1921 is the product NDC for Amoxicillin And Clavulanate Potassium, Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL for suspension, listed with the FDA by Redpharm Drug. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Amoxicillin And Clavulanate Potassium.
What is the active ingredient?
Amoxicillin, Clavulanate potassium.
Who is the labeler?
Redpharm Drug, NDC labeler code 67296. 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 And Clavulanate Potassium?
200 other product NDCs are listed under this name. See all Amoxicillin And Clavulanate Potassium 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 And Clavulanate Potassium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-475870518-4758-00
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-417968788-4179-01
Amoxicillin And Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralCoupler LLC67046-036667046-0366-03
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralCoupler LLC67046-095567046-0955-03
Amoxicillin and Clavulanate PotassiumAmoxicillin 562.5 mg/1 + 2 more ingredientsTablet, Film coated, Extended releaseOralUSAntibiotics, LLC81964-22081964-0220-2881964-0220-40
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-442470518-4424-00
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-883668788-8836-02
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLSuspensionOralPreferred Pharmaceuticals Inc.68788-877068788-8770-0168788-8770-07
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralDevatis, Inc.73043-00673043-0006-20
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralDevatis, Inc.73043-00773043-0007-20

All 201 Amoxicillin And Clavulanate Potassium NDCs

Other NDCs under NDA 050755

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

FDA NDC Directory listings under NDA 050755
ProductStrengthForm · routeLabelerProduct NDC
Amoxicillin And Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLFor suspensionOralNuCare Pharmaceuticals, Inc.68071-3774
Amoxicillin And Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLFor suspensionOralUSAntibiotics, LLC81964-203
Augmentin ES-600amoxicillin and clavulanate potassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLFor suspensionOralUSAntibiotics, LLC81964-003

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