Amoxicillin
- Product NDC
- 50090-0711
- 11-digit product format
- 500900711
- Labeler code
- 50090
- Product ID
- 50090-0711_12dede2a-303c-4486-98c6-69b04e5b44d4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA065255
- Marketing category
- ANDA
- Marketing start
- 2006-03-29
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN
- Active strength
- 875 mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC],Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-0711-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-444d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use Amoxicillin Tablets, USP safely and effectively. See full prescribing information for Amoxicillin Tablets, USP. AMOXICILLIN tablets, USP, for oral administration 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 suspected to be caused by bacteria. |
| 50090-0711-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-444d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use Amoxicillin Tablets, USP safely and effectively. See full prescribing information for Amoxicillin Tablets, USP. AMOXICILLIN tablets, USP, for oral administration 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 suspected to be caused by bacteria. |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-0711-0 | Amoxicillin | 20 in 1 BOTTLE | TABLET, COATED | 20 | | 10 |
| 50090-0711-2 | Amoxicillin | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-0711 | AMOXICILLIN TABLET, COATED [A-S MEDICATION SOLUTIONS] | 10 | Legacy NDC, 2 package rows | 20190325_0817cc63-8724-4e9c-9531-fab4406597e4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-0711-0 | 50090071100 | 20 TABLET, COATED in 1 BOTTLE (50090-0711-0) | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-0711-2 | 50090071102 | 30 TABLET, COATED in 1 BOTTLE (50090-0711-2) | 2014-11-28 | 0000-00-00 | No | No | Current |