Amoxicillin and Clavulanate Potassium
- Product NDC
- 21695-215
- 11-digit product format
- 216950215
- Labeler code
- 21695
- Product ID
- 21695-215_6d794bf5-8ce7-449c-9cc5-d3b6b0380cfb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA065096
- Marketing category
- ANDA
- Marketing start
- 2002-10-29
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 875 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 |
|---|
| 21695-215-20 | Amoxicillin and Clavulanate Potassium | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 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 [REBEL DISTRIBUTORS CORP.] | 1 | |
| clavulanate potassium | ACTIVE INGREDIENT | Q42OMW3AT8 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| amoxicillin | ACTIVE MOIETY | 804826J2HU | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| clavulanic acid | ACTIVE MOIETY | 23521W1S24 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| hypromellose | INACTIVE INGREDIENT | 3NXW29V3WO | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| polydextrose | INACTIVE INGREDIENT | VH2XOU12IE | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| polyethylene glycol | INACTIVE INGREDIENT | 3WJQ0SDW1A | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
| triacetin | INACTIVE INGREDIENT | XHX3C3X673 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-215 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.] | 1 | Legacy NDC, 1 package rows | 20100225_d0459c2a-2de1-4f19-acee-c1bd664f3342.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-215-20 | 21695021520 | 20 in 1 BOTTLE | Historical |