Azithromycin
- Product NDC
- 68788-8246
- 11-digit product format
- 687888246
- Labeler code
- 68788
- Product ID
- 68788-8246_c18ef483-f7cf-402c-a099-25f821ce13f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA211147
- Marketing category
- ANDA
- Marketing start
- 2022-08-25
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 200 mg/5mL
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azithromycin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN DIHYDRATE | 200 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 141963 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8246-3 | Azithromycin | 30 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 30 | | 7 |
| 68788-8246-3 | Azithromycin | 1 in 1 CARTON | POWDER, FOR SUSPENSION | 1 | | 7 |
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 |
|---|
| 68788-8246-3 | 68788824603 | 1 BOTTLE in 1 CARTON (68788-8246-3) / 30 mL in 1 BOTTLE | 1 bottle | 2022-08-25 | 0000-00-00 | No | No | Current |