AMOXICILLIN AND CLAVULANATE POTASSIUM
- Product NDC
- 81964-212
- 11-digit product format
- 819640212
- Labeler code
- 81964
- Product ID
- 81964-212_3854c6ad-10f7-dae3-e063-6294a90ae00a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- USAntibiotics, LLC
- Application
- NDA050575
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-12-05
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 125; 31.25 mg/5mL; mg/5mL
- 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 table| Ingredient | Strength |
|---|
| AMOXICILLIN | 125 mg/5mL |
| CLAVULANATE POTASSIUM | 31.25 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 562508, 617302, 617322 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81964-212-01 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 75 mL in 1 BOTTLE | FOR SUSPENSION | 75 | | 5 |
| 81964-212-03 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 100 mL in 1 BOTTLE | FOR SUSPENSION | 100 | | 5 |
| 81964-212-05 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 150 mL in 1 BOTTLE | FOR SUSPENSION | 150 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81964-212 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, COATED AMOXICILLIN AND CLAVULANATE POTASSIUM FOR SUSPENSION [USANTIBIOTICS, LLC] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240518_c4a6deb5-0bcd-4fa3-b19b-a82fa1dd14f3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 81964-212-01 | 81964021201 | 75 mL in 1 BOTTLE (81964-212-01) | 75 ml | 2022-12-05 | 0000-00-00 | No | No | Current |
| 81964-212-03 | 81964021203 | 100 mL in 1 BOTTLE (81964-212-03) | 100 ml | 2022-12-05 | 0000-00-00 | No | No | Current |
| 81964-212-05 | 81964021205 | 150 mL in 1 BOTTLE (81964-212-05) | 150 ml | 2022-12-05 | 0000-00-00 | No | No | Current |