Amoxicillin and Clavulanate Potassium
- Product NDC
- 53002-7898
- 11-digit product format
- 530027898
- Labeler code
- 53002
- Product ID
- 53002-7898_c70c27b5-95a5-4daf-aa00-6a97412ef8e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amoxicillin and clavulanate potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA065093
- Marketing category
- ANDA
- Marketing start
- 2002-11-21
- 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
- 2021-12-31
- 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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-7898-1 | Amoxicillin and Clavulanate Potassium | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 7 | |
| 53002-7898-4 | Amoxicillin and Clavulanate Potassium | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | 7 | |
| 53002-7898-6 | Amoxicillin and Clavulanate Potassium | 6 in 1 BOTTLE | TABLET, FILM COATED | 6 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-7898 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 7 | Legacy NDC, 3 package rows | 20230609_2a45ce33-8523-4635-ad56-da4c2cb9f02e.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 562508 | amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet | PSN | 2a45ce33-8523-4635-ad56-da4c2cb9f02e | 7 |
| 562508 | amoxicillin 875 MG / clavulanate 125 MG Oral Tablet | SCD | 2a45ce33-8523-4635-ad56-da4c2cb9f02e | 7 |
| 562508 | amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | 2a45ce33-8523-4635-ad56-da4c2cb9f02e | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 53002-7898-1 | 53002789801 | 10 TABLET, FILM COATED in 1 BOTTLE (53002-7898-1) | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-7898-4 | 53002789804 | 14 TABLET, FILM COATED in 1 BOTTLE (53002-7898-4) | 2017-10-01 | 0000-00-00 | No | No | Current |
| 53002-7898-6 | 53002789806 | 6 TABLET, FILM COATED in 1 BOTTLE (53002-7898-6) | 2017-10-01 | 0000-00-00 | No | No | Current |