AZITHROMYCIN
- Product NDC
- 68071-4795
- 11-digit product format
- 680714795
- Labeler code
- 68071
- Product ID
- 68071-4795_1adc57cf-712e-75b9-e063-6294a90a0de0
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4795-3 | AZITHROMYCIN | 30 mL in 1 BOX | POWDER, FOR SUSPENSION | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4795 | AZITHROMYCIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240706_8389c336-25eb-a96f-e053-2a91aa0a0dd8.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 |
|---|
| 68071-4795-3 | 68071479503 | 30 mL in 1 BOX (68071-4795-3) | 30 ml | 2019-03-07 | 0000-00-00 | No | No | Current |