AMOXICILLIN AND CLAVULANATE POTASSIUM
- Product NDC
- 81964-203
- 11-digit product format
- 819640203
- Labeler code
- 81964
- Product ID
- 81964-203_3a120204-39ce-43cd-e063-6394a90a9f19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amoxicillin and clavulanate potassium
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- USAntibiotics, LLC
- Application
- NDA050755
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-09-19
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 600; 42.9 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 | 600 mg/5mL |
| CLAVULANATE POTASSIUM | 42.9 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 617993 |
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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81964-203-51 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 75 mL in 1 BOTTLE | FOR SUSPENSION | 75 | 5 | |
| 81964-203-54 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 200 mL in 1 BOTTLE | FOR SUSPENSION | 200 | 5 | |
| 81964-203-69 | AMOXICILLIN AND CLAVULANATE POTASSIUM | 125 mL in 1 BOTTLE | FOR SUSPENSION | 125 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 81964-203-51 | ML - Milliliter | 81964-203 | 4ddaaf1c-0011-418c-ac2f-20e31f53e55a | 1 | 2022-11-07 |
| 81964-203-54 | ML - Milliliter | 81964-203 | efca6360-a191-438b-a7fc-56b21ddc1ce3 | 1 | 2022-11-07 |
| 81964-203-69 | ML - Milliliter | 81964-203 | cbfaa09d-475a-4907-90c3-7bffc26909e9 | 1 | 2022-11-07 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension | PSN | 7d4dfd6f-bd1a-4acc-8506-07fca08f8a38 | 5 |
| 617993 | amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension | SCD | 7d4dfd6f-bd1a-4acc-8506-07fca08f8a38 | 5 |
| 617993 | amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension | SY | 7d4dfd6f-bd1a-4acc-8506-07fca08f8a38 | 5 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension | SY | 7d4dfd6f-bd1a-4acc-8506-07fca08f8a38 | 5 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension | PSN | 2fbb57ba-08d8-0224-e063-6294a90ab683 | 3 |
| 617993 | amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension | SCD | 2fbb57ba-08d8-0224-e063-6294a90ab683 | 3 |
| 617993 | amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension | SY | 2fbb57ba-08d8-0224-e063-6294a90ab683 | 3 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension | SY | 2fbb57ba-08d8-0224-e063-6294a90ab683 | 3 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG in 5 mL Oral Suspension | PSN | 2bb03d3b-5d44-bc4a-e063-6394a90a656a | 1 |
| 617993 | amoxicillin 120 MG/ML / clavulanate 8.58 MG/ML Oral Suspension | SCD | 2bb03d3b-5d44-bc4a-e063-6394a90a656a | 1 |
| 617993 | amoxicillin (as amoxicillin trihydrate) 600 MG / clavulanic acid (as clavulanate potassium) 42.9 MG per 5 ML Oral Suspension | SY | 2bb03d3b-5d44-bc4a-e063-6394a90a656a | 1 |
| 617993 | amoxicillin 600 MG / clavulanic acid 42.9 MG per 5 ML Oral Suspension | SY | 2bb03d3b-5d44-bc4a-e063-6394a90a656a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 81964-203-51 | 81964020351 | 75 mL in 1 BOTTLE (81964-203-51) | 75 ml | 2022-09-19 | 0000-00-00 | No | No | Current |
| 81964-203-54 | 81964020354 | 200 mL in 1 BOTTLE (81964-203-54) | 200 ml | 2022-09-19 | 0000-00-00 | No | No | Current |
| 81964-203-69 | 81964020369 | 125 mL in 1 BOTTLE (81964-203-69) | 125 ml | 2022-09-19 | 0000-00-00 | No | No | Current |