Amoxicillin
- Product NDC
- 68788-8731
- 11-digit product format
- 687888731
- Labeler code
- 68788
- Product ID
- 68788-8731_f1194a1f-53b3-46d4-9dc5-112f9e0eb773
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA065119
- Marketing category
- ANDA
- Marketing start
- 2024-09-16
- Substance
- AMOXICILLIN
- Active strength
- 400 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 | 400 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU |
| Rxcui | 308189 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8731-1 | Amoxicillin | 100 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8731 | AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 1 package rows | 20250205_8dfbaa75-87ba-4a6b-a2db-176441a842af.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 |
|---|
| 68788-8731-1 | 68788873101 | 100 mL in 1 BOTTLE (68788-8731-1) | 100 ml | 2024-09-16 | No | No | Historical |