Amoxicillin and Clavulanate Potassium
- Product NDC
- 42571-164
- 11-digit product format
- 425710164
- Labeler code
- 42571
- Product ID
- 42571-164_22ff093e-19eb-7dd4-e063-6394a90ac20d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Micro Labs Limited
- Application
- ANDA205187
- Marketing category
- ANDA
- Marketing start
- 2021-07-01
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 400; 57 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
- 2026-12-31
- Current FDA listing
- Yes
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 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| 8690a824-4bf8-4d1e-b118-2d6dda86bc04 | Product name | 2 | 20161206 |
| cf3f1c02-1f32-2322-3314-b70ebbf5610e | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
| ebb3e917-326a-9e18-0354-a19c9f63a2f3 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42571-164-47 | Amoxicillin and Clavulanate Potassium | 100 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 100 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42571-164-47 | ML - Milliliter | 42571-164 | 1685882c-0bb5-478b-9293-97d4f65ddb48 | 1 | 2022-02-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 42571-164 | AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) POWDER, FOR SUSPENSION [MICRO LABS LIMITED] | 8 | Current NDC, Legacy NDC, 1 package rows | 20240927_8ea86ac2-174b-4da0-963f-6a051dccbe36.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617423 | amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral Suspension | PSN | 8ea86ac2-174b-4da0-963f-6a051dccbe36 | 8 |
| 617430 | amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral Suspension | PSN | 8ea86ac2-174b-4da0-963f-6a051dccbe36 | 8 |
| 617423 | amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral Suspension | SCD | 8ea86ac2-174b-4da0-963f-6a051dccbe36 | 8 |
| 617430 | amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral Suspension | SCD | 8ea86ac2-174b-4da0-963f-6a051dccbe36 | 8 |
| 617423 | amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral Suspension | SY | 8ea86ac2-174b-4da0-963f-6a051dccbe36 | 8 |
| 617430 | amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral Suspension | SY | 8ea86ac2-174b-4da0-963f-6a051dccbe36 | 8 |
| 617423 | amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral Suspension | SY | 8ea86ac2-174b-4da0-963f-6a051dccbe36 | 8 |
| 617430 | amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral Suspension | SY | 8ea86ac2-174b-4da0-963f-6a051dccbe36 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 42571-164-47 | 42571016447 | 100 mL in 1 BOTTLE (42571-164-47) | 100 ml | 2021-07-01 | 0000-00-00 | No | No | Current |