AZASITE
- Product NDC
- 82584-307
- 11-digit product format
- 825840307
- Labeler code
- 82584
- Product ID
- 82584-307_1e292167-581f-b1db-e063-6394a90ae8a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Thea Pharma Inc.
- Application
- NDA050810
- Marketing category
- NDA
- Marketing start
- 2022-11-01
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AZASITE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN MONOHYDRATE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JTE4MNN1MD |
| Rxcui | 706868, 706872 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82584-307-02 | AZASITE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
| 82584-307-02 | AZASITE | 2.5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2.5 | | 4 |
| 82584-307-03 | AZASITE | 2.5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2.5 | | 4 |
| 82584-307-03 | AZASITE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82584-307 | AZASITE (AZITHROMYCIN MONOHYDRATE) SOLUTION/ DROPS [THEA PHARMA INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240730_0c5d6f5e-18ea-436f-8c62-bbaf66effe3d.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 |
|---|
| 82584-307-02 | 82584030702 | 1 BOTTLE, DROPPER in 1 CARTON (82584-307-02) / 2.5 mL in 1 BOTTLE, DROPPER | 2022-11-01 | 0000-00-00 | Yes | No | Current |
| 82584-307-03 | 82584030703 | 1 BOTTLE, DROPPER in 1 CARTON (82584-307-03) / 2.5 mL in 1 BOTTLE, DROPPER | 2022-11-01 | 0000-00-00 | No | No | Current |