Amoxicillin and Clavulanate Potassium
- Product NDC
- 63187-542
- 11-digit product format
- 631870542
- Labeler code
- 63187
- Product ID
- 63187-542_51ae03ae-99b0-47e9-ae80-0e8e7b1fc7bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amoxicillin and clavulanate potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA065098
- Marketing category
- ANDA
- Marketing start
- 2004-08-13
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 200 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMOXICILLIN | ACTIVE INGREDIENT | 804826J2HU | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| CLAVULANATE POTASSIUM | ACTIVE INGREDIENT | Q42OMW3AT8 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| CLAVULANIC ACID | ACTIVE MOIETY | 23521W1S24 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| CARAMEL | INACTIVE INGREDIENT | T9D99G2B1R | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| ORANGE | INACTIVE INGREDIENT | 5EVU04N5QU | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| RASPBERRY | INACTIVE INGREDIENT | 4N14V5R27W | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-542 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 3 | Legacy NDC | 20210114_0f263ead-5be2-435e-9e5d-8f23fb1707e3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-542-00 | 63187054200 | 100 mL in 1 BOTTLE (63187-542-00) | 100 ml | 2018-12-01 | 0000-00-00 | No | No | Current |