Amoxicillin and Clavulanate Potassium
- Product NDC
- 0093-2277
- 11-digit product format
- 000932277
- Labeler code
- 0093
- Product ID
- 0093-2277_aaf9ce2f-41c3-489c-b5c1-f4f553d84854
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA065089
- Marketing category
- ANDA
- Marketing start
- 2005-01-13
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 200; 28.5 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin and Clavulanate Potassium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMOXICILLIN | 200 mg/5mL |
| CLAVULANATE POTASSIUM | 28.5 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 562508, 617296, 617423, 617430 |
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 |
| ed912195-5da0-0f2f-6f4b-3ef17710cbe3 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0093-2277-73 | Amoxicillin and Clavulanate Potassium | 100 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 100 | 31 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-2277-73 | ML - Milliliter | 0093-2277 | 9383c744-c091-48a8-84a5-2cc8e9e48325 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0093-2277 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA, INC.] | 29 | Current NDC, Legacy NDC, 1 package rows | 20240824_963e7bea-ff5d-420a-9cb2-e4aefb534b33.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 | 963e7bea-ff5d-420a-9cb2-e4aefb534b33 | 31 |
| 617430 | amoxicillin 400 MG / clavulanic acid 57 MG in 5 mL Oral Suspension | PSN | 963e7bea-ff5d-420a-9cb2-e4aefb534b33 | 31 |
| 617296 | amoxicillin 500 MG / clavulanate potassium 125 MG Oral Tablet | PSN | 963e7bea-ff5d-420a-9cb2-e4aefb534b33 | 31 |
| 562508 | amoxicillin 875 MG / clavulanate potassium 125 MG Oral Tablet | PSN | 963e7bea-ff5d-420a-9cb2-e4aefb534b33 | 31 |
| 617423 | amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral Suspension | SCD | 963e7bea-ff5d-420a-9cb2-e4aefb534b33 | 31 |
| 617296 | amoxicillin 500 MG / clavulanate 125 MG Oral Tablet | SCD | 963e7bea-ff5d-420a-9cb2-e4aefb534b33 | 31 |
| 617430 | amoxicillin 80 MG/ML / clavulanate 11.4 MG/ML Oral Suspension | SCD | 963e7bea-ff5d-420a-9cb2-e4aefb534b33 | 31 |
| 562508 | amoxicillin 875 MG / clavulanate 125 MG Oral Tablet | SCD | 963e7bea-ff5d-420a-9cb2-e4aefb534b33 | 31 |
| 617423 | amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral Suspension | SY | 963e7bea-ff5d-420a-9cb2-e4aefb534b33 | 31 |
| 617430 | amoxicillin (as amoxicillin trihydrate) 400 MG / clavulanic acid (as clavulanate potassium) 57 MG per 5 ML Oral Suspension | SY | 963e7bea-ff5d-420a-9cb2-e4aefb534b33 | 31 |
| 617296 | amoxicillin (as amoxicillin trihydrate) 500 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | 963e7bea-ff5d-420a-9cb2-e4aefb534b33 | 31 |
| 562508 | amoxicillin (as amoxicillin trihydrate) 875 MG / clavulanic acid (as clavulanate potassium) 125 MG Oral Tablet | SY | 963e7bea-ff5d-420a-9cb2-e4aefb534b33 | 31 |
| 617423 | amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral Suspension | SY | 963e7bea-ff5d-420a-9cb2-e4aefb534b33 | 31 |
| 617430 | amoxicillin 400 MG / clavulanic acid 57 MG per 5 ML Oral Suspension | SY | 963e7bea-ff5d-420a-9cb2-e4aefb534b33 | 31 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0093-2277-73 | 00093227773 | 100 mL in 1 BOTTLE (0093-2277-73) | 100 ml | 2005-01-13 | 0000-00-00 | No | No | Current |