Azithromycin
- Product NDC
- 43386-471
- 11-digit product format
- 433860471
- Labeler code
- 43386
- Product ID
- 43386-471_ab3a02b3-6189-4b1f-a9eb-d02b9e313fb3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA065488
- Marketing category
- ANDA
- Marketing start
- 2017-09-27
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 200 mg/5mL
- Pharmacologic classes
- Macrolide Antimicrobial [EPC],Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-471-61 | Azithromycin | 1 in 1 CARTON | FOR SUSPENSION | 1 | | 3 |
| 43386-471-61 | Azithromycin | 30 mL in 1 BOTTLE | FOR SUSPENSION | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-471 | AZITHROMYCIN FOR SUSPENSION [LUPIN PHARMACEUTICALS,INC.] | 3 | Legacy NDC, 2 package rows | 20191221_0ab1486a-b890-45a1-9bfc-cf72d7cb9dd1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43386-471-61 | 43386047161 | 1 BOTTLE in 1 CARTON (43386-471-61) > 30 mL in 1 BOTTLE | 1 bottle | 2017-09-27 | 0000-00-00 | No | No | Current |