Amoxicillin
- Product NDC
- 68788-8759
- 11-digit product format
- 687888759
- Labeler code
- 68788
- Product ID
- 68788-8759_4c858be1-f077-4602-b424-bf8b8c7d4da4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA065322
- Marketing category
- ANDA
- Marketing start
- 2024-10-17
- Substance
- AMOXICILLIN
- Active strength
- 250 mg/5mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMOXICILLIN | 250 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU |
| Rxcui | 239191 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8759-1 | Amoxicillin | 150 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 150 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8759 | AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 1 package rows | 20241024_0ce05282-995c-461e-b807-facb1fcbb405.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8759-1 | 68788875901 | 150 mL in 1 BOTTLE (68788-8759-1) | 150 ml | 2024-10-17 | No | No | Historical |