Amoxicillin
- Product NDC
- 50090-0303
- 11-digit product format
- 500900303
- Labeler code
- 50090
- Product ID
- 50090-0303_e75fbaba-4f77-4479-a6f9-c29b682e4808
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA065291
- Marketing category
- ANDA
- Marketing start
- 2007-03-01
- Substance
- AMOXICILLIN
- Active strength
- 500 mg/1
- 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU |
| Rxcui | 308191 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-0303-0 | 2023-03-03 | C162847 | 48780-1 | 9d75b9d0-370f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974 |
| 50090-0303-1 | 2023-03-03 | C162847 | 48780-1 | 9d75b9d0-370f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974 |
| 50090-0303-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-370f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974 |
| 50090-0303-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-370f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974 |
| 50090-0303-0 | 2021-02-20 | C162847 | 48780-1 | 9d75b9d0-370f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974 |
| 50090-0303-1 | 2021-02-20 | C162847 | 48780-1 | 9d75b9d0-370f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974 |
| 50090-0303-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-370f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, for oral use. Initial U.S. Approval: 1974 |
| 50090-0303-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-370f-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES . AMOXICILLIN Capsules, 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 |
|---|
| 50090-0303-0 | Amoxicillin | 14 in 1 BOTTLE | CAPSULE | 14 | | 29 |
| 50090-0303-1 | Amoxicillin | 60 in 1 BOTTLE | CAPSULE | 60 | | 29 |
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 |
|---|
| 50090-0303-0 | 50090030300 | 14 CAPSULE in 1 BOTTLE (50090-0303-0) | 14 capsule | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-0303-1 | 50090030301 | 60 CAPSULE in 1 BOTTLE (50090-0303-1) | 60 capsule | 2017-10-02 | 0000-00-00 | No | No | Current |