Amoxicillin and Clavulanate Potassium
- Product NDC
- 69452-337
- 11-digit product format
- 694520337
- Labeler code
- 69452
- Product ID
- 69452-337_3d370466-2b90-4d0b-9bf8-6297353d18ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bionpharma Inc.
- Application
- ANDA065063
- Marketing category
- ANDA
- Marketing start
- 2022-08-01
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 875 mg/1; mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69452-337-11 | EA - Each | 69452-337 | 3580008b-54fe-473e-ab4a-680db554931c | 1 | 2022-11-07 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 562508 | amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet | PSN | 31d00820-1c20-d52b-e063-6394a90ac312 | 1 |
| 562508 | amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet | PSN | 348f7f77-ba7e-5dd9-e063-6294a90a0991 | 1 |
| 562508 | amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet | PSN | 377abca8-7076-9ad0-e063-6294a90aa5dc | 1 |
| 562508 | amoxicillin 875 MG / clavulanate 125 MG Oral Tablet | SCD | 31d00820-1c20-d52b-e063-6394a90ac312 | 1 |
| 562508 | amoxicillin 875 MG / clavulanate 125 MG Oral Tablet | SCD | 348f7f77-ba7e-5dd9-e063-6294a90a0991 | 1 |
| 562508 | amoxicillin 875 MG / clavulanate 125 MG Oral Tablet | SCD | 377abca8-7076-9ad0-e063-6294a90aa5dc | 1 |
| 562508 | amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | 31d00820-1c20-d52b-e063-6394a90ac312 | 1 |
| 562508 | amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | 348f7f77-ba7e-5dd9-e063-6294a90a0991 | 1 |
| 562508 | amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | 377abca8-7076-9ad0-e063-6294a90aa5dc | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69452-337-11 | 69452033711 | 20 TABLET, FILM COATED in 1 BOTTLE (69452-337-11) | 2022-08-01 | 0000-00-00 | No | No | Current |