Amoxicillin and Clavulanate Potassium
- Product NDC
- 0093-8675
- 11-digit product format
- 000938675
- Labeler code
- 0093
- Product ID
- 0093-8675_2faf9b29-5df4-4f3c-84d9-6866f91b87e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA065162
- Marketing category
- ANDA
- Marketing start
- 2004-09-23
- 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
- 2027-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0093-8675-74 | Amoxicillin and Clavulanate Potassium | 200 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 200 | | 19 |
| 0093-8675-75 | Amoxicillin and Clavulanate Potassium | 125 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 125 | | 19 |
| 0093-8675-78 | Amoxicillin and Clavulanate Potassium | 75 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 75 | | 19 |
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 [TEVA PHARMACEUTICALS USA INC] | 9 | |
| CLAVULANATE POTASSIUM | ACTIVE INGREDIENT | Q42OMW3AT8 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 9 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 9 | |
| CLAVULANIC ACID | ACTIVE MOIETY | 23521W1S24 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 9 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 9 | |
| ANHYDROUS TRISODIUM CITRATE | INACTIVE INGREDIENT | RS7A450LGA | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 9 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 9 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 9 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 9 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 9 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA INC] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-8675 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [TEVA PHARMACEUTICALS USA, INC.] | 17 | Current NDC, Legacy NDC, 3 package rows | 20250216_e83f43dd-f79e-4166-9bee-9427e235c876.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0093-8675-74 | 00093867574 | 200 mL in 1 BOTTLE (0093-8675-74) | 200 ml | 2004-09-23 | 0000-00-00 | No | No | Current |
| 0093-8675-75 | 00093867575 | 125 mL in 1 BOTTLE (0093-8675-75) | 125 ml | 2004-09-23 | 0000-00-00 | No | No | Current |
| 0093-8675-78 | 00093867578 | 75 mL in 1 BOTTLE (0093-8675-78) | 75 ml | 2004-09-23 | 0000-00-00 | No | No | Current |