Amoxicillin and Clavulanate Potassium
- Product NDC
- 63187-488
- 11-digit product format
- 631870488
- Labeler code
- 63187
- Product ID
- 63187-488_aad9c785-d8dd-4b2a-8d48-82cd342e3c16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin and Clavulanate Potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA065063
- Marketing category
- ANDA
- Marketing start
- 2002-03-14
- 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 |
|---|
| 63187-488-14 | Amoxicillin and Clavulanate Potassium | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 6 |
| 63187-488-20 | Amoxicillin and Clavulanate Potassium | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 6 |
| 63187-488-28 | Amoxicillin and Clavulanate Potassium | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 6 |
| 63187-488-30 | Amoxicillin and Clavulanate Potassium | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 63187-488-40 | Amoxicillin and Clavulanate Potassium | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | | 6 |
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 [PROFICIENT RX LP] | 1 | |
| CLAVULANATE POTASSIUM | ACTIVE INGREDIENT | Q42OMW3AT8 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CLAVULANIC ACID | ACTIVE MOIETY | 23521W1S24 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-488 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [PROFICIENT RX LP] | 6 | Current NDC, Legacy NDC, 5 package rows | 20220521_5b68b2bf-b581-4372-87be-a6394ee56961.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 |
|---|
| 63187-488-14 | 63187048814 | 14 TABLET, FILM COATED in 1 BOTTLE (63187-488-14) | 2021-09-16 | 0000-00-00 | No | No | Current |
| 63187-488-20 | 63187048820 | 20 TABLET, FILM COATED in 1 BOTTLE (63187-488-20) | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-488-28 | 63187048828 | 28 TABLET, FILM COATED in 1 BOTTLE (63187-488-28) | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-488-30 | 63187048830 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-488-30) | 2015-02-02 | 0000-00-00 | No | No | Current |
| 63187-488-40 | 63187048840 | 40 TABLET, FILM COATED in 1 BOTTLE (63187-488-40) | 2015-02-02 | 0000-00-00 | No | No | Current |