azithromycin monohydrate
- Product NDC
- 71205-427
- 11-digit product format
- 712050427
- Labeler code
- 71205
- Product ID
- 71205-427_79679395-12e4-4440-a9b7-12ffef1ef36c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA065398
- Marketing category
- ANDA
- Marketing start
- 2015-08-18
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-427 | AZITHROMYCIN MONOHYDRATE TABLET [PROFICIENT RX LP] | 2 | Legacy NDC | 20221111_093775a6-1177-4f3c-aa0c-587e68e43150.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71205-427-06 | 71205042706 | 1 BLISTER PACK in 1 CARTON (71205-427-06) > 6 TABLET in 1 BLISTER PACK | 1 blister pack | 2020-03-16 | 0000-00-00 | No | No | Current |