Amoxicillin and Clavulanate Potassium
- Product NDC
- 45865-418
- 11-digit product format
- 458650418
- Labeler code
- 45865
- Product ID
- 45865-418_9ab204d5-bc31-a818-e053-2995a90ad0da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA091568
- Marketing category
- ANDA
- Marketing start
- 2012-01-20
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN; CLAVULANATE POTASSIUM
- Active strength
- 875 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
- 2020-12-31
- 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 |
|---|
| 45865-418-20 | Amoxicillin and Clavulanate Potassium | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 2 |
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 [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CLAVULANATE POTASSIUM | ACTIVE INGREDIENT | Q42OMW3AT8 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CLAVULANIC ACID | ACTIVE MOIETY | 23521W1S24 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| HYPROMELLOSE 2910 (15000 MPA.S) | INACTIVE INGREDIENT | 288VBX44JC | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-418 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 2 | Legacy NDC, 1 package rows | 20191228_1d73e25f-69e5-3845-e054-00144ff8d46c.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 |
|---|
| 45865-418-20 | 45865041820 | 20 TABLET, FILM COATED in 1 BOTTLE (45865-418-20) | 2015-08-26 | 0000-00-00 | No | No | Current |