Amoxicillin
- Product NDC
- 21695-384
- 11-digit product format
- 216950384
- Labeler code
- 21695
- Product ID
- 21695-384_61b292ba-a739-444d-896e-be204bfd9a1a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA061931
- Marketing category
- ANDA
- Marketing start
- 2010-02-01
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN
- Active strength
- 125 mg/5mL
- 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 |
|---|
| 21695-384-15 | Amoxicillin | 150 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 150 | | 1 |
| 21695-384-80 | Amoxicillin | 80 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 80 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMOXICILLIN | ACTIVE INGREDIENT | 804826J2HU | AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] | 1 | |
| AMOXICILLIN | ACTIVE MOIETY | 804826J2HU | AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-384 | AMOXICILLIN POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP.] | 1 | Legacy NDC, 2 package rows | 20100225_e82de7ec-0ca3-4afb-aa09-5ec5e7895b9d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 21695-384-15 | 21695038415 | 150 mL in 1 BOTTLE | 150 ml | Historical |
| 21695-384-80 | 21695038480 | 80 mL in 1 BOTTLE | 80 ml | Historical |