Amoxicillin and Clavulanate Potassium
- Product NDC
- 73043-009
- 11-digit product format
- 730430009
- Labeler code
- 73043
- Product ID
- 73043-009_8942c376-8b1a-4716-9b90-de14ab22c4fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Devatis, Inc.
- Application
- ANDA210416
- Marketing category
- ANDA
- Marketing start
- 2024-11-01
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 400; 57 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 | 400 mg/5mL |
| CLAVULANATE POTASSIUM | 57 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 617430 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73043-009-01 | Amoxicillin and Clavulanate Potassium | 50 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 50 | | 2 |
| 73043-009-02 | Amoxicillin and Clavulanate Potassium | 75 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 75 | | 2 |
| 73043-009-03 | Amoxicillin and Clavulanate Potassium | 100 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73043-009 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [DEVATIS, INC.] | 2 | Current NDC, 3 package rows | 20250316_90d0aa94-5c32-4fb7-8561-8763810d2847.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 73043-009-01 | 73043000901 | 50 mL in 1 BOTTLE (73043-009-01) | 50 ml | 2024-11-01 | No | No | Current |
| 73043-009-02 | 73043000902 | 75 mL in 1 BOTTLE (73043-009-02) | 75 ml | 2024-11-01 | No | No | Current |
| 73043-009-03 | 73043000903 | 100 mL in 1 BOTTLE (73043-009-03) | 100 ml | 2024-11-01 | No | No | Current |