Amoxicillin
- Product NDC
- 68788-8611
- 11-digit product format
- 687888611
- Labeler code
- 68788
- Product ID
- 68788-8611_0d540257-d438-43e3-bbea-52b293791002
- 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
- 2024-03-20
- Substance
- AMOXICILLIN
- Active strength
- 200 mg/5mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 68788-8611_0d540257-d438-43e3-bbea-52b293791002
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Amoxicillin
- Generic name
- Amoxicillin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Marketing start
- 2024-03-20
- Marketing category
- ANDA
- Application number
- ANDA065119
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC]; Penicillins [CS]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| AMOXICILLIN | 200 mg/5mL |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 804826J2HU |
| Rxcui | 313850 |
| Spl Set Id | c84082fc-ea07-4e73-99c5-8356b957a1c5 |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 804826J2HU | AMOXICILLIN | 61336-70-7 | AMOXICILLIN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8611-1 | 68788861101 | 100 mL in 1 BOTTLE (68788-8611-1) | 100 ml | 2024-03-20 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Amoxicillin | Preferred Pharmaceuticals Inc. | 2025-01-03 | HUMAN PRESCRIPTION DRUG LABEL | 2 |