Amoxicillin and Clavulanate Potassium
- Product NDC
- 16714-293
- 11-digit product format
- 167140293
- Labeler code
- 16714
- Product ID
- 16714-293_581a5622-f3ca-4a4f-9241-9810694c791a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA201090
- Marketing category
- ANDA
- Marketing start
- 2011-12-20
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin and Clavulanate Potassium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMOXICILLIN | 400 mg/5mL |
| CLAVULANATE POTASSIUM | 57 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 617423, 617430 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-293-01 | Amoxicillin and Clavulanate Potassium | 50 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 50 | | 13 |
| 16714-293-02 | Amoxicillin and Clavulanate Potassium | 75 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 75 | | 13 |
| 16714-293-03 | Amoxicillin and Clavulanate Potassium | 100 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 100 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMOXICILLIN | ACTIVE INGREDIENT | 804826J2HU | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 3 | |
| CLAVULANATE POTASSIUM | ACTIVE INGREDIENT | Q42OMW3AT8 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 3 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 3 | |
| CLAVULANIC ACID | ACTIVE MOIETY | 23521W1S24 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 3 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 3 | |
| HYPROMELLOSE 2910 (50 MPA.S) | INACTIVE INGREDIENT | 1IVH67816N | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 3 | |
| ORANGE | INACTIVE INGREDIENT | 5EVU04N5QU | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 3 | |
| SUCCINIC ACID | INACTIVE INGREDIENT | AB6MNQ6J6L | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 3 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-293 | AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] | 13 | Current NDC, Legacy NDC, 3 package rows | 20240723_f0a6d21d-203f-4fde-b010-a2730b86b491.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-293-01 | 16714029301 | 50 mL in 1 BOTTLE (16714-293-01) | 50 ml | 2011-12-20 | 0000-00-00 | No | No | Current |
| 16714-293-02 | 16714029302 | 75 mL in 1 BOTTLE (16714-293-02) | 75 ml | 2011-12-20 | 0000-00-00 | No | No | Current |
| 16714-293-03 | 16714029303 | 100 mL in 1 BOTTLE (16714-293-03) | 100 ml | 2011-12-20 | 0000-00-00 | No | No | Current |