Amoxicillin and Clavulanate Potassium
- Product NDC
- 53808-0759
- 11-digit product format
- 538080759
- Labeler code
- 53808
- Product ID
- 53808-0759_e30a8bdd-87ca-4886-a55e-d807763bd4c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMOXICILLIN AND CLAVULANATE POTASSIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA065189
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 250 mg/1; mg/1
- Pharmacologic classes
- beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53808-0759-1 | Amoxicillin and Clavulanate Potassium | 1 in 1 DOSE PACK | TABLET, FILM COATED | 1 | | 1 |
| 53808-0759-1 | Amoxicillin and Clavulanate Potassium | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 1 |
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 [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CLAVULANATE POTASSIUM | ACTIVE INGREDIENT | Q42OMW3AT8 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| AMOXICILLIN | ACTIVE MOIETY | 804826J2HU | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CLAVULANIC ACID | ACTIVE MOIETY | 23521W1S24 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53808-0759 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 2 package rows | 20100805_7f725b99-c327-4ba4-a3cb-356f344be778.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-0759-1 | 53808075901 | 1 in 1 DOSE PACK | Historical |