Amoxicillin
- Product NDC
- 68071-1675
- 11-digit product format
- 680711675
- Labeler code
- 68071
- Product ID
- 68071-1675_2a31a975-72fc-2a16-e063-6394a90a8149
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA065325
- Marketing category
- ANDA
- Marketing start
- 2006-06-19
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-1675-1 | 2024-07-15 | C162847 | 48780-1 | ba0f9c33-2f01-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN for Oral Suspension, USP. AMOXICILLIN for Oral Suspension, USP, for oral use Dye free Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly susp |
| 68071-1675-1 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-2f01-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN for Oral Suspension, USP. AMOXICILLIN for Oral Suspension, USP, for oral use Dye free Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly susp |
| 68071-1675-1 | 2021-02-11 | C162847 | 48780-1 | ba0f9c33-2f01-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN for Oral Suspension, USP. AMOXICILLIN for Oral Suspension, USP, for oral use Dye free Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly susp |
| 68071-1675-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2f01-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN for Oral Suspension, USP. AMOXICILLIN for Oral Suspension, USP, for oral use Dye free Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly susp |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-1675-1 | Amoxicillin | 100 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-1675 | AMOXICILLIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241228_59a546ed-84b7-a54a-e053-2991aa0a3a0d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-1675-1 | 68071167501 | 100 mL in 1 BOTTLE (68071-1675-1) | 100 ml | 2017-09-20 | 0000-00-00 | No | No | Current |