azithromycin monohydrate
- Product NDC
- 70518-0803
- 11-digit product format
- 705180803
- Labeler code
- 70518
- Product ID
- 70518-0803_e26d507e-f780-2c85-e053-2995a90a5482
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA065398
- Marketing category
- ANDA
- Marketing start
- 2017-10-23
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN MONOHYDRATE
- 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
FDA-Initiated Inactive NDC Indexing#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-0803 | AZITHROMYCIN MONOHYDRATE TABLET [REMEDYREPACK INC.] | 6 | Legacy NDC | 20220628_8b3f7811-55db-475f-beb5-90124e732b21.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-0803-0 | 70518080300 | 6 TABLET in 1 BLISTER PACK (70518-0803-0) | 6 tablet | 2017-10-23 | 0000-00-00 | No | No | Current |