Azithromycin Dihydrate
- Product NDC
- 70518-3501
- 11-digit product format
- 705183501
- Labeler code
- 70518
- Product ID
- 70518-3501_e76594d6-739a-5d57-e053-2a95a90a99af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA208250
- Marketing category
- ANDA
- Marketing start
- 2022-08-29
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 250 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 |
|---|
| 70518-3501 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [REMEDYREPACK INC.] | 4 | Legacy NDC | 20241010_efa7b126-71d2-43be-b3dc-32536217d308.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3501-0 | 70518350100 | 6 TABLET, FILM COATED in 1 BLISTER PACK (70518-3501-0) | 2022-08-29 | 0000-00-00 | No | No | Current |
| 70518-3501-1 | 70518350101 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3501-1) | 2022-08-29 | 0000-00-00 | No | No | Current |