Azithromycin
- Product NDC
- 50111-789
- 11-digit product format
- 501110789
- Labeler code
- 50111
- Product ID
- 50111-789_d6a6e6e8-3842-49a7-883b-82aa0916f3c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA065218
- Marketing category
- ANDA
- Marketing start
- 2005-12-01
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 600 mg/1
- 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
- Azithromycin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN MONOHYDRATE | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JTE4MNN1MD |
| Rxcui | 204844 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50111-789-10 | Azithromycin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50111-789 | AZITHROMYCIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] | 12 | Current NDC, Legacy NDC, 1 package rows | 20220810_ac549022-4d7f-4c9f-9244-1a2df9a27276.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 |
|---|
| 50111-789-10 | 50111078910 | 30 TABLET, FILM COATED in 1 BOTTLE (50111-789-10) | 2005-12-01 | 0000-00-00 | No | No | Current |