Amoxicillin and Clavulanate Potassium
- Product NDC
- 21695-767
- 11-digit product format
- 216950767
- Labeler code
- 21695
- Product ID
- 21695-767_2970fe7e-9e1f-47aa-85ad-663ee15c7e06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA065066
- Marketing category
- ANDA
- Marketing start
- 2002-06-05
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-767-50 | Amoxicillin and Clavulanate Potassium | 50 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 50 | | 1 |
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 [REBEL DISTRIBUTORS CORP] | 1 | |
| CLAVULANATE POTASSIUM | ACTIVE INGREDIENT | Q42OMW3AT8 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| CLAVULANIC ACID | ACTIVE MOIETY | 23521W1S24 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| ORANGE | INACTIVE INGREDIENT | 5EVU04N5QU | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| SUCCINIC ACID | INACTIVE INGREDIENT | AB6MNQ6J6L | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-767 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20110726_2970fe7e-9e1f-47aa-85ad-663ee15c7e06.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 21695-767-50 | 21695076750 | 50 mL in 1 BOTTLE | 50 ml | Historical |