Amoxicillin and Clavulanate Potassium
- Product NDC
- 55289-767
- 11-digit product format
- 552890767
- Labeler code
- 55289
- Product ID
- 55289-767_419b4e87-cb8b-8fbc-e063-6394a90a3b7c
- 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 |
|---|
| 55289-767-10 | Amoxicillin and Clavulanate Potassium | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | | 30 |
| 55289-767-14 | Amoxicillin and Clavulanate Potassium | 14 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 14 | | 30 |
| 55289-767-20 | Amoxicillin and Clavulanate Potassium | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 30 |
| 55289-767-21 | Amoxicillin and Clavulanate Potassium | 21 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 21 | | 30 |
| 55289-767-28 | Amoxicillin and Clavulanate Potassium | 28 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 28 | | 30 |
| 55289-767-30 | Amoxicillin and Clavulanate Potassium | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 30 |
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.] | 6 | |
| CLAVULANATE POTASSIUM | ACTIVE INGREDIENT | Q42OMW3AT8 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| CLAVULANIC ACID | ACTIVE MOIETY | 23521W1S24 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-767 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 29 | Current NDC, Legacy NDC, 6 package rows | 20241006_e340b67b-332e-4e0c-aebf-ad4872dc5ed4.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 |
|---|
| 55289-767-10 | 55289076710 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-10) | 2011-01-25 | 0000-00-00 | No | No | Current |
| 55289-767-14 | 55289076714 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-14) | 2011-01-25 | 0000-00-00 | No | No | Current |
| 55289-767-20 | 55289076720 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-20) | 2011-01-25 | 0000-00-00 | No | No | Current |
| 55289-767-21 | 55289076721 | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-21) | 2011-01-25 | 0000-00-00 | No | No | Current |
| 55289-767-28 | 55289076728 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-28) | 2011-01-25 | 0000-00-00 | No | No | Current |
| 55289-767-30 | 55289076730 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-30) | 2011-01-25 | 0000-00-00 | No | No | Current |