Amoxicillin and Clavulanate Potassium
- Product NDC
- 21695-401
- 11-digit product format
- 216950401
- Labeler code
- 21695
- Product ID
- 21695-401_b58ec5f9-0715-4562-9aeb-915329a4eef8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA065358
- Marketing category
- ANDA
- Marketing start
- 2007-08-13
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 600 mg/5mL; mg/5mL
- Pharmacologic classes
- 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 |
|---|
| 21695-401-12 | Amoxicillin and Clavulanate Potassium | 125 mL in 1 BOTTLE, DISPENSING | SUSPENSION | 125 | | 2 |
| 21695-401-20 | Amoxicillin and Clavulanate Potassium | 200 mL in 1 BOTTLE, DISPENSING | SUSPENSION | 200 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-401 | AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [REBEL DISTRIBUTORS CORP.] | 2 | Legacy NDC, 2 package rows | 20101123_b58ec5f9-0715-4562-9aeb-915329a4eef8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 21695-401-12 | 21695040112 | 125 mL in 1 BOTTLE, DISPENSING | 125 ml | Historical |
| 21695-401-20 | 21695040120 | 200 mL in 1 BOTTLE, DISPENSING | 200 ml | Historical |