Amoxicillin
- Product NDC
- 50090-3005
- 11-digit product format
- 500903005
- Labeler code
- 50090
- Product ID
- 50090-3005_6c6b0037-6273-4041-9f92-26eddcbe77e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA061931
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN
- Active strength
- 125 mg/5mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC],Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 50090-3005-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-ecfb-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, and AMOXICILLIN TABLETS (CHEWABLE) safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, and AMOXICILLIN TABLETS (CHEWABLE). AMOXICILLIN capsules, AMOXICILLIN for oral suspension, and AMOXICILLIN tablets (chewable) for oral use Initial U.S. Approval: 1974 |
| 50090-3005-0 | 2021-06-10 | C162847 | 48780-1 | 9d75b9d0-ecfb-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, and AMOXICILLIN TABLETS (CHEWABLE) safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, and AMOXICILLIN TABLETS (CHEWABLE). AMOXICILLIN capsules, AMOXICILLIN for oral suspension, and AMOXICILLIN tablets (chewable) for oral use Initial U.S. Approval: 1974 |
| 50090-3005-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ecfb-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, and AMOXICILLIN TABLETS (CHEWABLE) safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES, AMOXICILLIN FOR ORAL SUSPENSION, and AMOXICILLIN TABLETS (CHEWABLE). AMOXICILLIN capsules, AMOXICILLIN for oral suspension, and AMOXICILLIN tablets (chewable) for oral use Initial U.S. Approval: 1974 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-3005-0 | Amoxicillin | 150 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 150 | | 29 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-3005 | AMOXICILLIN TABLET, CHEWABLE AMOXICILLIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS] | 29 | Legacy NDC, 1 package rows | 20240510_63b395ca-f0ea-4429-b8aa-18f495596e4d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 50090-3005-0 | 50090300500 | 150 mL in 1 BOTTLE | 150 ml | Historical |