azithromycin monohydrate
- Product NDC
- 68071-3169
- 11-digit product format
- 680713169
- Labeler code
- 68071
- Product ID
- 68071-3169_bb13ca9a-442c-8fb4-e053-2a95a90a1b5a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA065399
- Marketing category
- ANDA
- Marketing start
- 2015-07-22
- 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
- 2022-12-31
- 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 |
|---|
| 68071-3169-5 | 68071316905 | 5 TABLET in 1 BOTTLE (68071-3169-5) | 5 tablet | 2017-03-15 | 0000-00-00 | No | No | Current |
| 68071-3169-6 | 68071316906 | 6 TABLET in 1 BOTTLE (68071-3169-6) | 6 tablet | 2017-03-15 | 0000-00-00 | No | No | Current |