Amoxicillin
- Product NDC
- 63187-335
- 11-digit product format
- 631870335
- Labeler code
- 63187
- Product ID
- 63187-335_ec3a6992-a66b-4fd9-8e43-eb1b616c673e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA065334
- Marketing category
- ANDA
- Marketing start
- 2006-12-28
- Substance
- AMOXICILLIN
- Active strength
- 400 mg/5mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMOXICILLIN | 400 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU |
| Rxcui | 308189 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-335-00 | Amoxicillin | 100 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 100 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMOXICILLIN | ACTIVE INGREDIENT | 804826J2HU | AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-335 | AMOXICILLIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 1 package rows | 20210915_e40f3e20-facf-46f4-89c7-3593bc27d0fc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-335-00 | 63187033500 | 100 mL in 1 BOTTLE (63187-335-00) | 100 ml | 2019-01-01 | 0000-00-00 | No | No | Current |