Azithromycin Dihydrate
- Product NDC
- 68788-8311
- 11-digit product format
- 687888311
- Labeler code
- 68788
- Product ID
- 68788-8311_4e3ca491-2729-4250-8475-f2c9be6ba86e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA208249
- Marketing category
- ANDA
- Marketing start
- 2022-12-20
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 500 mg/1
- 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 Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8311 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 3 | Legacy NDC | 20250207_4e3ca491-2729-4250-8475-f2c9be6ba86e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-8311-3 | 68788831103 | 1 BLISTER PACK in 1 CARTON (68788-8311-3) > 3 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2022-12-20 | 0000-00-00 | No | No | Current |