Amoxicillin and Clavulanate Potassium
- Product NDC
- 43063-077
- 11-digit product format
- 430630077
- Labeler code
- 43063
- Product ID
- 43063-077_413731a6-a006-1bb0-e063-6294a90ac8eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA065096
- Marketing category
- ANDA
- Marketing start
- 2002-10-31
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 875; 125 mg/1; mg/1
- 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 | 875 mg/1 |
| CLAVULANATE POTASSIUM | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 562508 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-077-03 | Amoxicillin and Clavulanate Potassium | 3 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 3 | | 31 |
| 43063-077-04 | Amoxicillin and Clavulanate Potassium | 4 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 4 | | 31 |
| 43063-077-06 | Amoxicillin and Clavulanate Potassium | 6 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 6 | | 31 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMOXICILLIN | ACTIVE INGREDIENT | 804826J2HU | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| CLAVULANATE POTASSIUM | ACTIVE INGREDIENT | Q42OMW3AT8 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| CLAVULANIC ACID | ACTIVE MOIETY | 23521W1S24 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-077 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 30 | Current NDC, Legacy NDC, 3 package rows | 20240809_b04330a0-2b8d-4cf9-a08e-19007d1001ad.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-077-03 | 43063007703 | 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-03) | 2009-02-26 | 0000-00-00 | No | No | Current |
| 43063-077-04 | 43063007704 | 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-04) | 2009-02-26 | 0000-00-00 | No | No | Current |
| 43063-077-06 | 43063007706 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-06) | 2009-02-26 | 0000-00-00 | No | No | Current |