Amoxicillin and Clavulanate Potassium
- Product NDC
- 65862-501
- 11-digit product format
- 658620501
- Labeler code
- 65862
- Product ID
- 65862-501_2b91e9f8-c77e-4330-8fc1-e574758f0db6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA091569
- Marketing category
- ANDA
- Marketing start
- 2012-01-20
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 250; 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 table| Ingredient | Strength |
|---|
| AMOXICILLIN | 250 mg/1 |
| CLAVULANATE POTASSIUM | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 562251, 562508, 617296 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-501-05 | Amoxicillin and Clavulanate Potassium | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 23 |
| 65862-501-30 | Amoxicillin and Clavulanate Potassium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-501 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 21 | Current NDC, Legacy NDC, 2 package rows | 20240821_ffb158a1-83ba-4100-9221-175aa986dc3e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65862-501-05 | 65862050105 | 500 TABLET, FILM COATED in 1 BOTTLE (65862-501-05) | 2012-01-20 | 0000-00-00 | No | No | Current |
| 65862-501-15 | 65862050115 | 1500 TABLET, FILM COATED in 1 BAG (65862-501-15) | 20-JAN-12 | | | | Current |
| 65862-501-30 | 65862050130 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-501-30) | 2012-01-20 | 0000-00-00 | No | No | Current |