Prescription drug · NDA AUTHORIZED GENERIC
Amoxicillin And Clavulanate Potassium NDC 67296-1921
Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL · For suspension · Oral · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-1921-7 | 6729619210767296192107 | 75 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
- Brand name (proprietary)
- Amoxicillin And Clavulanate Potassium
- 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
N467296192107followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Amoxicillin And Clavulanate Potassium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amoxicillin And Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-4758 | 70518-4758-00 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-4179 | 68788-4179-01 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0366 | 67046-0366-03 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0955 | 67046-0955-03 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 562.5 mg/1 + 2 more ingredients | Tablet, Film coated, Extended releaseOral | USAntibiotics, LLC | 81964-220 | 81964-0220-2881964-0220-40 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4424 | 70518-4424-00 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8836 | 68788-8836-02 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | SuspensionOral | Preferred Pharmaceuticals Inc. | 68788-8770 | 68788-8770-0168788-8770-07 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Devatis, Inc. | 73043-006 | 73043-0006-20 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Devatis, Inc. | 73043-007 | 73043-0007-20 |
Other NDCs under NDA 050755
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Amoxicillin And Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | For suspensionOral | NuCare Pharmaceuticals, Inc. | 68071-3774 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | For suspensionOral | USAntibiotics, LLC | 81964-203 |
| Augmentin ES-600amoxicillin and clavulanate potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | For suspensionOral | USAntibiotics, LLC | 81964-003 |