Amoxicillin
- Product NDC
- 70518-4521
- 11-digit product format
- 705184521
- Labeler code
- 70518
- Product ID
- 70518-4521_445880d3-1f4e-d825-e063-6294a90a9c45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA065378
- Marketing category
- ANDA
- Marketing start
- 2025-11-21
- Substance
- AMOXICILLIN
- Active strength
- 400 mg/5mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin
- Listing expiration
- 2026-12-31
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 |
|---|
| 70518-4521-0 | Amoxicillin | 100 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 100 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4521-0 | 70518452100 | 100 mL in 1 BOTTLE (70518-4521-0) | 100 ml | 2025-11-21 | No | No | Historical |