azithromycin monohydrate
- Product NDC
- 68180-161
- 11-digit product format
- 681800161
- Labeler code
- 68180
- Product ID
- 68180-161_4ef8b11c-ff56-4110-beda-2e09c3923514
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA065399
- Marketing category
- ANDA
- Marketing start
- 2015-08-18
- Marketing end
- 2024-07-31
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 500 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 |
|---|---|---|---|---|---|
| 68180-161-06 | EA - Each | 68180-161 | 3fe4b0ba-cb59-48b9-af3f-35fb799e4044 | 1 | 2015-09-10 |
| 68180-161-11 | EA - Each | 68180-161 | 4069c822-8811-48bb-a964-8db83d692869 | 1 | 2021-10-08 |
| 68180-161-13 | EA - Each | 68180-161 | 31319cf4-aa03-4dce-9f8c-6824e470ae1b | 1 | 2015-09-10 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 248656 | azithromycin 500 MG Oral Tablet | PSN | de58d218-7127-46f2-8578-e7a5c02140d1 | 6 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | de58d218-7127-46f2-8578-e7a5c02140d1 | 6 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | de58d218-7127-46f2-8578-e7a5c02140d1 | 6 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | 4a3a000d-baee-74a3-e054-00144ff88e88 | 2 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | 764193ca-7fdd-4e3b-aa52-cc8777936fba | 2 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | 4a3a000d-baee-74a3-e054-00144ff88e88 | 2 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | 764193ca-7fdd-4e3b-aa52-cc8777936fba | 2 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | 4a3a000d-baee-74a3-e054-00144ff88e88 | 2 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | 764193ca-7fdd-4e3b-aa52-cc8777936fba | 2 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | 4d8a9adc-36f4-4f83-a153-c7979967d316 | 1 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | f07ac620-b9a3-4aa4-92cc-dde90e52670d | 1 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | 4d8a9adc-36f4-4f83-a153-c7979967d316 | 1 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | f07ac620-b9a3-4aa4-92cc-dde90e52670d | 1 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | 4d8a9adc-36f4-4f83-a153-c7979967d316 | 1 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | f07ac620-b9a3-4aa4-92cc-dde90e52670d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68180-161-06 | 68180016106 | 30 TABLET in 1 CONTAINER (68180-161-06) | 30 tablet | 2015-08-18 | 0000-00-00 | No | No | Current |
| 68180-161-11 | 68180016111 | 1 BLISTER PACK in 1 CARTON (68180-161-11) > 3 TABLET in 1 BLISTER PACK | 1 blister pack | 2020-06-15 | 0000-00-00 | No | No | Current |
| 68180-161-13 | 68180016113 | 3 BLISTER PACK in 1 CARTON (68180-161-13) > 3 TABLET in 1 BLISTER PACK | 3 blister pack | 2015-08-18 | 0000-00-00 | No | No | Current |