azithromycin monohydrate
- Product NDC
- 43063-715
- 11-digit product format
- 430630715
- Labeler code
- 43063
- Product ID
- 43063-715_dc151476-398d-3eaa-e053-2a95a90a62c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA065399
- Marketing category
- ANDA
- Marketing start
- 2015-08-18
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN MONOHYDRATE
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-715-02 | 43063071502 | 2 TABLET in 1 BOTTLE, PLASTIC (43063-715-02) | 2 tablet | 2016-10-12 | 0000-00-00 | No | No | Current |