Amoxicillin and Clavulanate Potassium
- Product NDC
- 63187-032
- 11-digit product format
- 631870032
- Labeler code
- 63187
- Product ID
- 63187-032_83901ad8-02a3-41a4-8c1d-cda4378c3b15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA065101
- Marketing category
- ANDA
- Marketing start
- 2002-10-31
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 500; 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 | 500 mg/1 |
| CLAVULANATE POTASSIUM | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 562508, 617296 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-032-06 | Amoxicillin and Clavulanate Potassium | 6 in 1 BOTTLE | TABLET, FILM COATED | 6 | | 8 |
| 63187-032-20 | Amoxicillin and Clavulanate Potassium | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 8 |
| 63187-032-21 | Amoxicillin and Clavulanate Potassium | 21 in 1 BOTTLE | TABLET, FILM COATED | 21 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-032 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 8 | Current NDC, Legacy NDC, 3 package rows | 20241019_482511ed-4531-45ec-a4eb-c600aeb03325.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 |
|---|
| 63187-032-06 | 63187003206 | 6 TABLET, FILM COATED in 1 BOTTLE (63187-032-06) | 2020-12-28 | 0000-00-00 | No | No | Current |
| 63187-032-20 | 63187003220 | 20 TABLET, FILM COATED in 1 BOTTLE (63187-032-20) | 2014-05-01 | 0000-00-00 | No | No | Current |
| 63187-032-21 | 63187003221 | 21 TABLET, FILM COATED in 1 BOTTLE (63187-032-21) | 2020-12-28 | 0000-00-00 | No | No | Current |