Azithromycin
- Product NDC
- 0781-5789
- 11-digit product format
- 007815789
- Labeler code
- 0781
- Product ID
- 0781-5789_fb14e5c8-7402-4475-be00-dc09f0a6b57f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA065212
- Marketing category
- ANDA
- Marketing start
- 2005-11-14
- Marketing end
- 2022-05-30
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0781-5789-03 | 00781578903 | 1 DOSE PACK in 1 CARTON (0781-5789-03) > 3 TABLET, FILM COATED in 1 DOSE PACK | 1 dose pack | 2017-03-02 | 0000-00-00 | No | No | Current |
| 0781-5789-31 | 00781578931 | 30 TABLET, FILM COATED in 1 BOTTLE (0781-5789-31) | | 2017-03-02 | 0000-00-00 | No | No | Current |