Amoxicillin and Clavulanate Potassium
- Product NDC
- 85766-079
- 11-digit product format
- 857660079
- Labeler code
- 85766
- Product ID
- 85766-079_50318ddb-122f-34dc-e063-6294a90a9dd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sportpharm LLC
- Application
- ANDA091569
- Marketing category
- ANDA
- Marketing start
- 2012-01-20
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 500; 125 mg/1; mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin and Clavulanate Potassium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMOXICILLIN | 500 mg/1 |
| CLAVULANATE POTASSIUM | 125 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | Q42OMW3AT8, 804826J2HU |
| Rxcui | 562251, 562508, 617296 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 502415e5-4ac7-4266-a01a-ef44aa3c028d | Product name | 7 | 20250623 |
| d0f377c9-74d8-e2e3-e06e-4d37534f5c0f | Product name | 3 | 20250620 |
| 2ebbc361-d28f-48a9-a286-c1ae09cdaf5c | Product name | 3 | 20230314 |
| 2bb254ff-3d7f-4bdb-abf9-476506008c55 | Product name | 1 | 20230117 |
| f33561b9-47cb-411c-a228-16c62e346cd4 | Product name | 1 | 20200415 |
| 8690a824-4bf8-4d1e-b118-2d6dda86bc04 | Product name | 2 | 20161206 |
| cf3f1c02-1f32-2322-3314-b70ebbf5610e | Product name | 1 | 20140508 |
| ebb3e917-326a-9e18-0354-a19c9f63a2f3 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85766-079-20 | Amoxicillin and Clavulanate Potassium | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 562251 | amoxicillin 250 MG / clavulanate potassium 125 MG Oral Tablet | PSN | fabeca32-3f26-4b65-b8b6-5f0e23765ab0 | 2 |
| 617296 | amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet | PSN | fabeca32-3f26-4b65-b8b6-5f0e23765ab0 | 2 |
| 562508 | amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet | PSN | fabeca32-3f26-4b65-b8b6-5f0e23765ab0 | 2 |
| 562251 | amoxicillin 250 MG / clavulanate 125 MG Oral Tablet | SCD | fabeca32-3f26-4b65-b8b6-5f0e23765ab0 | 2 |
| 617296 | amoxicillin 500 MG / clavulanate 125 MG Oral Tablet | SCD | fabeca32-3f26-4b65-b8b6-5f0e23765ab0 | 2 |
| 562508 | amoxicillin 875 MG / clavulanate 125 MG Oral Tablet | SCD | fabeca32-3f26-4b65-b8b6-5f0e23765ab0 | 2 |
| 562251 | amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | fabeca32-3f26-4b65-b8b6-5f0e23765ab0 | 2 |
| 617296 | amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | fabeca32-3f26-4b65-b8b6-5f0e23765ab0 | 2 |
| 562508 | amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | fabeca32-3f26-4b65-b8b6-5f0e23765ab0 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 85766-079-20 | 85766007920 | 20 TABLET, FILM COATED in 1 BOTTLE (85766-079-20) | 2025-10-15 | No | No | Historical |