AMOXICILLIN AND CLAVULANATE POTASSIUM
- Product NDC
- 81964-575
- 11-digit product format
- 819640575
- Labeler code
- 81964
- Product ID
- 81964-575_3854c6ad-10f7-dae3-e063-6294a90ae00a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amoxicillin and clavulanate potassium
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- USAntibiotics, LLC
- Application
- NDA050720
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2025-07-02
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 875; 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AMOXICILLIN AND CLAVULANATE POTASSIUM
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMOXICILLIN | 875 mg/1 |
| CLAVULANATE POTASSIUM | 125 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 562508, 617302, 617322 |
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 |
|---|---|---|---|---|---|---|
| 81964-575-83 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 180 in 1 BOTTLE | TABLET, COATED | 180 | 5 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617302 | amoxicillin 125 MG / clavulanic acid 31.25 MG in 5 mL Oral Suspension | PSN | c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3 | 5 |
| 617322 | amoxicillin 250 MG / clavulanic acid 62.5 MG in 5 mL Oral Suspension | PSN | c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3 | 5 |
| 562508 | amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet | PSN | c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3 | 5 |
| 617302 | amoxicillin 25 MG/ML / clavulanate 6.25 MG/ML Oral Suspension | SCD | c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3 | 5 |
| 617322 | amoxicillin 50 MG/ML / clavulanate 12.5 MG/ML Oral Suspension | SCD | c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3 | 5 |
| 562508 | amoxicillin 875 MG / clavulanate 125 MG Oral Tablet | SCD | c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3 | 5 |
| 617302 | amoxicillin (as amoxicillin trihydrate) 25 MG/ML / clavulanate (as clavulanate potassium) 6.25 MG/ML Oral Suspension | SY | c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3 | 5 |
| 617322 | amoxicillin (as amoxicillin trihydrate) 250 MG / clavulanic acid (as clavulanate potassium) 62.5 MG per 5 Oral Suspension | SY | c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3 | 5 |
| 562508 | amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3 | 5 |
| 617302 | amoxicillin 125 MG / clavulanic acid 31.25 MG per 5 ML Oral Suspension | SY | c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3 | 5 |
| 617322 | amoxicillin 250 MG / clavulanic acid 62.5 MG per 5 ML Oral Suspension | SY | c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 81964-575-83 | 81964057583 | 180 TABLET, COATED in 1 BOTTLE (81964-575-83) | 2025-07-02 | No | No | Current |