AzaSITE
- Product NDC
- 17478-307
- 11-digit product format
- 174780307
- Labeler code
- 17478
- Product ID
- 17478-307_1a5cc030-9de6-4918-a165-ccad89d6f2ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Monohydrate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- NDA050810
- Marketing category
- NDA
- Marketing start
- 2014-05-14
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 17478-307-01 | AzaSITE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 6 |
| 17478-307-01 | AzaSITE | 1 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 1 | | 6 |
| 17478-307-03 | AzaSITE | 2.5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2.5 | | 6 |
| 17478-307-03 | AzaSITE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 6 |
| 17478-307-04 | AzaSITE | 2.5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2.5 | | 6 |
| 17478-307-04 | AzaSITE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Azithromycin Monohydrate | ACTIVE INGREDIENT | JTE4MNN1MD | AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Azithromycin Anhydrous | ACTIVE MOIETY | J2KLZ20U1M | AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Benzalkonium Chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Mannitol | INACTIVE INGREDIENT | 3OWL53L36A | AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Poloxamer 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Polycarbophil | INACTIVE INGREDIENT | W25LM17A4W | AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] | 2 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17478-307 | AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [AKORN] | 6 | Legacy NDC, 6 package rows | 20220503_14ae4c07-b042-452a-b069-2b41bc646e04.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 |
|---|
| 17478-307-01 | 17478030701 | 1 BOTTLE, DROPPER in 1 CARTON (17478-307-01) > 1 mL in 1 BOTTLE, DROPPER | 2014-05-14 | 0000-00-00 | No | No | Current |
| 17478-307-03 | 17478030703 | 1 BOTTLE, DROPPER in 1 CARTON (17478-307-03) > 2.5 mL in 1 BOTTLE, DROPPER | 2014-05-14 | 0000-00-00 | No | No | Current |
| 17478-307-04 | 17478030704 | 1 BOTTLE, DROPPER in 1 CARTON (17478-307-04) > 2.5 mL in 1 BOTTLE, DROPPER | 2014-05-14 | 0000-00-00 | No | No | Current |