AZITHROMYCIN
- Product NDC
- 68071-3897
- 11-digit product format
- 680713897
- Labeler code
- 68071
- Product ID
- 68071-3897_3f7c742b-a360-bef8-e063-6294a90a93ed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA207531
- Marketing category
- ANDA
- Marketing start
- 2018-04-10
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 200 mg/5mL
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AZITHROMYCIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN MONOHYDRATE | 200 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JTE4MNN1MD |
| Rxcui | 141963 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3897-2 | AZITHROMYCIN | 22.5 mL in 1 BOTTLE, PLASTIC | POWDER, FOR SUSPENSION | 22.5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3897-2 | 68071389702 | 22.5 mL in 1 BOTTLE, PLASTIC (68071-3897-2) | 22.5 ml | 2025-09-23 | No | No | Current |