Amoxicillin and clavulanate potassium
- Product NDC
- 42571-395
- 11-digit product format
- 425710395
- Labeler code
- 42571
- Product ID
- 42571-395_2bd14acf-1437-ec8d-e063-6394a90adc4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and clavulanate potassium
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- Micro Labs Limited
- Application
- ANDA217805
- Marketing category
- ANDA
- Marketing start
- 2024-04-01
- 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 |
|---|
| 42571-395-46 | Amoxicillin and clavulanate potassium | 75 mL in 1 BOTTLE | FOR SUSPENSION | 75 | | 3 |
| 42571-395-70 | Amoxicillin and clavulanate potassium | 125 mL in 1 BOTTLE | FOR SUSPENSION | 125 | | 3 |
| 42571-395-77 | Amoxicillin and clavulanate potassium | 200 mL in 1 BOTTLE | FOR SUSPENSION | 200 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-395 | AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) FOR SUSPENSION [MICRO LABS LIMITED] | 3 | Current NDC, 3 package rows | 20250117_26992a71-e4a0-4e41-aa3c-3219868c2226.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 |
|---|
| 42571-395-46 | 42571039546 | 75 mL in 1 BOTTLE (42571-395-46) | 75 ml | 2024-04-01 | No | No | Current |
| 42571-395-70 | 42571039570 | 125 mL in 1 BOTTLE (42571-395-70) | 125 ml | 2024-04-01 | No | No | Current |
| 42571-395-77 | 42571039577 | 200 mL in 1 BOTTLE (42571-395-77) | 200 ml | 2024-04-01 | No | No | Current |