Amoxicillin and Clavulanate Potassium
- Product NDC
- 68788-8157
- 11-digit product format
- 687888157
- Labeler code
- 68788
- Product ID
- 68788-8157_37ecdfb0-b355-4550-9f29-685eabad0264
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA065358
- Marketing category
- ANDA
- Marketing start
- 2022-03-17
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin and Clavulanate Potassium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMOXICILLIN | 600 mg/5mL |
| CLAVULANATE POTASSIUM | 42.9 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 617993 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8157-1 | Amoxicillin and Clavulanate Potassium | 125 mL in 1 BOTTLE, DISPENSING | SUSPENSION | 125 | | 5 |
| 68788-8157-7 | Amoxicillin and Clavulanate Potassium | 75 mL in 1 BOTTLE, DISPENSING | SUSPENSION | 75 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8157 | AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240214_720ee5cf-1962-423b-ac81-6dd4f02b9206.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 |
|---|
| 68788-8157-1 | 68788815701 | 125 mL in 1 BOTTLE, DISPENSING (68788-8157-1) | 125 ml | 2022-03-17 | 0000-00-00 | No | No | Current |
| 68788-8157-7 | 68788815707 | 75 mL in 1 BOTTLE, DISPENSING (68788-8157-7) | 75 ml | 2022-03-17 | 0000-00-00 | No | No | Current |