Amoxicillin and Clavulanate Potassium
- Product NDC
- 43598-220
- 11-digit product format
- 435980220
- Labeler code
- 43598
- Product ID
- 43598-220_281d6c99-708d-bd90-e14e-dd9e6749db4b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amoxicillin and clavulanate potassium
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Inc
- Application
- NDA050785
- Marketing category
- NDA
- Marketing start
- 2003-09-11
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM
- Active strength
- 563 mg/1; mg/1; mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC],Penicillins [CS],Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|---|---|---|---|---|---|
| 43598-220-28 | Amoxicillin and Clavulanate Potassium Extended Release | 28 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 28 | 6 | |
| 43598-220-40 | Amoxicillin and Clavulanate Potassium Extended Release | 40 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 40 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43598-220-28 | EA - Each | 43598-220 | 3d5be574-acff-4e3a-8e9f-24c8defd9e52 | 1 | 2012-07-24 |
| 43598-220-40 | EA - Each | 43598-220 | ebc18559-da18-46d2-90d1-f8a770c0ecf6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43598-220 | AMOXICILLIN AND CLAVULANATE POTASSIUM EXTENDED RELEASE (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC] | 6 | Legacy NDC, 2 package rows | 20141014_fc4bb4b0-9330-4701-a600-199c42fb3255.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617995 | amoxicillin 1000 MG / clavulanate potassium 62.5 MG 12HR Extended Release Oral Tablet | PSN | fc4bb4b0-9330-4701-a600-199c42fb3255 | 6 |
| 617995 | 12 HR amoxicillin 1000 MG / clavulanate 62.5 MG Extended Release Oral Tablet | SCD | fc4bb4b0-9330-4701-a600-199c42fb3255 | 6 |
| 617995 | amoxicillin 1000 MG / clavulanate 62.5 MG 12 HR Extended Release Oral Tablet | SY | fc4bb4b0-9330-4701-a600-199c42fb3255 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 43598-220-28 | 43598022028 | 28 in 1 BOTTLE | Historical |
| 43598-220-40 | 43598022040 | 40 in 1 BOTTLE | Historical |