Amoxicillin and Clavulanate Potassium
- Product NDC
- 63187-857
- 11-digit product format
- 631870857
- Labeler code
- 63187
- Product ID
- 63187-857_665eb028-198a-4309-97c8-e4f97f1b7bba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA065162
- Marketing category
- ANDA
- Marketing start
- 2004-09-23
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 600; 42.9 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 | 600 mg/5mL |
| CLAVULANATE POTASSIUM | 42.9 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 617993 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-857-12 | Amoxicillin and Clavulanate Potassium | 125 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 125 | | 7 |
| 63187-857-20 | Amoxicillin and Clavulanate Potassium | 200 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 200 | | 7 |
| 63187-857-75 | Amoxicillin and Clavulanate Potassium | 75 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 75 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-857 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 7 | Current NDC, Legacy NDC, 3 package rows | 20220609_3a7248ca-2855-433e-aabc-42f0bb0db118.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 |
|---|
| 63187-857-12 | 63187085712 | 125 mL in 1 BOTTLE (63187-857-12) | 125 ml | 2017-06-01 | 0000-00-00 | No | No | Current |
| 63187-857-20 | 63187085720 | 200 mL in 1 BOTTLE (63187-857-20) | 200 ml | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-857-75 | 63187085775 | 75 mL in 1 BOTTLE (63187-857-75) | 75 ml | 2019-09-01 | 0000-00-00 | No | No | Current |