Azithromycin
- Product NDC
- 66116-524
- 11-digit product format
- 661160524
- Labeler code
- 66116
- Product ID
- 66116-524_4e9ac94f-4d85-4731-8b7f-6188209b4a9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Monohydrate
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- MedVantx, Inc.
- Application
- ANDA065419
- Marketing category
- ANDA
- Marketing start
- 2008-09-22
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 200 mg/5mL
- Pharmacologic classes
- Macrolide Antimicrobial [EPC],Macrolides [CS]
- 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 |
|---|
| 66116-524-30 | Azithromycin | 30 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 30 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AZITHROMYCIN MONOHYDRATE | ACTIVE INGREDIENT | JTE4MNN1MD | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.] | 1 | |
| AZITHROMYCIN ANHYDROUS | ACTIVE MOIETY | J2KLZ20U1M | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.] | 1 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.] | 1 | |
| ETHYL VANILLIN | INACTIVE INGREDIENT | YC9ST449YJ | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.] | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.] | 1 | |
| SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE | INACTIVE INGREDIENT | B70850QPHR | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.] | 1 | |
| VANILLIN | INACTIVE INGREDIENT | CHI530446X | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66116-524 | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) POWDER, FOR SUSPENSION [MEDVANTX, INC.] | 1 | Legacy NDC, 1 package rows | 20140328_4e9ac94f-4d85-4731-8b7f-6188209b4a9c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 66116-524-30 | 66116052430 | 30 mL in 1 BOTTLE | 30 ml | Historical |