Amoxicillin and Clavulanate Potassium
- Product NDC
- 50090-0996
- 11-digit product format
- 500900996
- Labeler code
- 50090
- Product ID
- 50090-0996_2c01fb53-2a62-415a-afb8-14d7be8de688
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA065373
- Marketing category
- ANDA
- Marketing start
- 2009-08-03
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 600 mg/5mL; mg/5mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 502415e5-4ac7-4266-a01a-ef44aa3c028d | Product name | 7 | 20250623 |
| d0f377c9-74d8-e2e3-e06e-4d37534f5c0f | Product name | 3 | 20250620 |
| 2ebbc361-d28f-48a9-a286-c1ae09cdaf5c | Product name | 3 | 20230314 |
| 2bb254ff-3d7f-4bdb-abf9-476506008c55 | Product name | 1 | 20230117 |
| f33561b9-47cb-411c-a228-16c62e346cd4 | Product name | 1 | 20200415 |
| 8690a824-4bf8-4d1e-b118-2d6dda86bc04 | Product name | 2 | 20161206 |
| cf3f1c02-1f32-2322-3314-b70ebbf5610e | Product name | 1 | 20140508 |
| ebb3e917-326a-9e18-0354-a19c9f63a2f3 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-0996-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-4474-f424-e053-dadaa90a57ce | Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL |
| 50090-0996-0 | 2020-02-13 | C162847 | 48780-1 | 9d75b9d0-4474-f424-e053-dadaa90a57ce | Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL |
| 50090-0996-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4474-f424-e053-dadaa90a57ce | Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-0996-0 | Amoxicillin and Clavulanate Potassium | 125 mL in 1 BOTTLE | SUSPENSION | 125 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-0996-0 | ML - Milliliter | 50090-0996 | 92c3a2d8-0c75-487f-b479-06b91a3c877f | 1 | 2018-10-11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-0996 | AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION [A-S MEDICATION SOLUTIONS] | 15 | Legacy NDC, 1 package rows | 20210223_ecbdb7e4-2a1c-4b72-9ae9-ed009c0eca1e.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension | PSN | ecbdb7e4-2a1c-4b72-9ae9-ed009c0eca1e | 15 |
| 617993 | amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension | SCD | ecbdb7e4-2a1c-4b72-9ae9-ed009c0eca1e | 15 |
| 617993 | amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension | SY | ecbdb7e4-2a1c-4b72-9ae9-ed009c0eca1e | 15 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension | SY | ecbdb7e4-2a1c-4b72-9ae9-ed009c0eca1e | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-0996-0 | 50090099600 | 125 mL in 1 BOTTLE (50090-0996-0) | 125 ml | 2014-11-28 | 0000-00-00 | No | No | Current |