Amoxicillin and Clavulanate Potassium
- Product NDC
- 55289-845
- 11-digit product format
- 552890845
- Labeler code
- 55289
- Product ID
- 55289-845_419b7d75-b6cc-e646-e063-6294a90a8d2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA065101
- Marketing category
- ANDA
- Marketing start
- 2002-10-31
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 500; 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 | 500 mg/1 |
| CLAVULANATE POTASSIUM | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU, Q42OMW3AT8 |
| Rxcui | 617296 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55289-845-06 | Amoxicillin and Clavulanate Potassium | 6 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 6 | | 31 |
| 55289-845-20 | Amoxicillin and Clavulanate Potassium | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 31 |
| 55289-845-21 | Amoxicillin and Clavulanate Potassium | 21 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 21 | | 31 |
| 55289-845-28 | Amoxicillin and Clavulanate Potassium | 28 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 28 | | 31 |
| 55289-845-30 | Amoxicillin and Clavulanate Potassium | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 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.] | 9 | |
| CLAVULANATE POTASSIUM | ACTIVE INGREDIENT | Q42OMW3AT8 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| CLAVULANIC ACID | ACTIVE MOIETY | 23521W1S24 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| HYPROMELLOSE 2910 (50 MPA.S) | INACTIVE INGREDIENT | 1IVH67816N | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-845 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 30 | Current NDC, Legacy NDC, 5 package rows | 20241006_cc445a39-d84c-4b76-9fb8-ae302e7cd96b.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 |
|---|
| 55289-845-06 | 55289084506 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-06) | 2012-12-06 | 0000-00-00 | No | No | Current |
| 55289-845-20 | 55289084520 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-20) | 2012-12-06 | 0000-00-00 | No | No | Current |
| 55289-845-21 | 55289084521 | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-21) | 2012-12-06 | 0000-00-00 | No | No | Current |
| 55289-845-28 | 55289084528 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-28) | 2012-12-06 | 0000-00-00 | No | No | Current |
| 55289-845-30 | 55289084530 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-30) | 2012-12-06 | 0000-00-00 | No | No | Current |