azithromycin monohydrate
- Product NDC
- 70518-3453
- 11-digit product format
- 705183453
- Labeler code
- 70518
- Product ID
- 70518-3453_e429a551-d19e-10a5-e053-2a95a90abdd7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA065399
- Marketing category
- ANDA
- Marketing start
- 2022-07-18
- 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
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3453-1 | 70518345301 | 1 BOX in 1 POUCH (70518-3453-1) > 30 TABLET in 1 BOX (70518-3453-0) | 1 box | 2022-07-18 | 0000-00-00 | No | No | Current |