Azithromycin Dihydrate
- Product NDC
- 50090-4601
- 11-digit product format
- 500904601
- Labeler code
- 50090
- Product ID
- 50090-4601_e5a7d412-de53-471b-a06e-68b3365865a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA208250
- Marketing category
- ANDA
- Marketing start
- 2019-07-01
- Marketing end
- 2026-11-30
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azithromycin Dihydrate
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN DIHYDRATE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 308460 |
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 |
|---|
| 50090-4601-0 | Azithromycin Dihydrate | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 17 |
| 50090-4601-0 | Azithromycin Dihydrate | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 17 |
| 50090-4601-1 | Azithromycin Dihydrate | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 17 |
| 50090-4601-1 | Azithromycin Dihydrate | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4601 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 15 | Current NDC, Legacy NDC, 4 package rows | 20250510_df9b39b7-d42d-4c4b-b492-9fd228978dec.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-4601-0 | 50090460100 | 1 BLISTER PACK in 1 CARTON (50090-4601-0) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2019-10-11 | 0000-00-00 | No | No | Current |
| 50090-4601-1 | 50090460101 | 1 BLISTER PACK in 1 CARTON (50090-4601-1) > 12 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2019-10-11 | 0000-00-00 | No | No | Current |