azithromycin monohydrate
- Product NDC
- 68180-160
- 11-digit product format
- 681800160
- Labeler code
- 68180
- Product ID
- 68180-160_4ef8b11c-ff56-4110-beda-2e09c3923514
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA065398
- Marketing category
- ANDA
- Marketing start
- 2015-08-18
- Marketing end
- 2024-07-31
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401 | Product name | 9 | 20200616 |
| a2cbe82e-b432-4f71-954b-75e9214e8567 | Product name | 3 | 20200612 |
| 371533fa-efb3-4c48-b5e4-60179db407f3 | Product name | 3 | 20190124 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68180-160-06 | EA - Each | 68180-160 | dec71861-3370-4a43-90f7-8b170bb6138a | 1 | 2015-09-10 |
| 68180-160-11 | EA - Each | 68180-160 | 9505f64c-0874-4e4a-835d-5cbacde90ca8 | 1 | 2021-10-08 |
| 68180-160-13 | EA - Each | 68180-160 | 32cdd4f5-c20f-47de-9cfa-aea9553d2c1f | 1 | 2015-09-10 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 749783 | {6 (azithromycin 250 MG Oral Tablet) } Pack | GPCK | 62d64414-d3ab-1741-e053-2a91aa0ac0f8 | 1 |
| 749783 | {6 (azithromycin 250 MG Oral Tablet) } Pack | GPCK | 92c05d6e-133a-b404-e053-2995a90a4ba8 | 1 |
| 749783 | {6 (azithromycin 250 MG Oral Tablet) } Pack | GPCK | a9ccb9b3-4da3-43d9-aa60-38e2baa771e3 | 1 |
| 308460 | azithromycin 250 MG Oral Tablet | PSN | 62d64414-d3ab-1741-e053-2a91aa0ac0f8 | 1 |
| 308460 | azithromycin 250 MG Oral Tablet | PSN | 92c05d6e-133a-b404-e053-2995a90a4ba8 | 1 |
| 308460 | azithromycin 250 MG Oral Tablet | PSN | a9ccb9b3-4da3-43d9-aa60-38e2baa771e3 | 1 |
| 749783 | azithromycin 250 MG Oral Tablet 6 Count Pack | PSN | 62d64414-d3ab-1741-e053-2a91aa0ac0f8 | 1 |
| 749783 | azithromycin 250 MG Oral Tablet 6 Count Pack | PSN | 92c05d6e-133a-b404-e053-2995a90a4ba8 | 1 |
| 749783 | azithromycin 250 MG Oral Tablet 6 Count Pack | PSN | a9ccb9b3-4da3-43d9-aa60-38e2baa771e3 | 1 |
| 308460 | azithromycin 250 MG Oral Tablet | SCD | 62d64414-d3ab-1741-e053-2a91aa0ac0f8 | 1 |
| 308460 | azithromycin 250 MG Oral Tablet | SCD | 92c05d6e-133a-b404-e053-2995a90a4ba8 | 1 |
| 308460 | azithromycin 250 MG Oral Tablet | SCD | a9ccb9b3-4da3-43d9-aa60-38e2baa771e3 | 1 |
| 749783 | azithromycin 250 MG Oral Tablet 6 Count Pack | SY | 62d64414-d3ab-1741-e053-2a91aa0ac0f8 | 1 |
| 749783 | azithromycin 250 MG Oral Tablet 6 Count Pack | SY | 92c05d6e-133a-b404-e053-2995a90a4ba8 | 1 |
| 749783 | azithromycin 250 MG Oral Tablet 6 Count Pack | SY | a9ccb9b3-4da3-43d9-aa60-38e2baa771e3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68180-160-06 | 68180016006 | 30 TABLET in 1 CONTAINER (68180-160-06) | 30 tablet | 2015-08-18 | 0000-00-00 | No | No | Current |
| 68180-160-11 | 68180016011 | 1 BLISTER PACK in 1 CARTON (68180-160-11) > 6 TABLET in 1 BLISTER PACK | 1 blister pack | 2020-06-15 | 0000-00-00 | No | No | Current |
| 68180-160-13 | 68180016013 | 3 BLISTER PACK in 1 CARTON (68180-160-13) > 6 TABLET in 1 BLISTER PACK | 3 blister pack | 2015-08-18 | 0000-00-00 | No | No | Current |