Azithromycin
- Product NDC
- 70436-019
- 11-digit product format
- 704360019
- Labeler code
- 70436
- Product ID
- 70436-019_ebe5ec1e-9891-ae48-e053-2a95a90afff6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Dihydrate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Slate Run Pharmaceuticals
- Application
- ANDA203412
- Marketing category
- ANDA
- Marketing start
- 2018-12-19
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 500 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 DIHYDRATE | 500 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 1668238 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70436-019-82 | Azithromycin | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 6 |
| 70436-019-82 | Azithromycin | 10 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70436-019 | AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SLATE RUN PHARMACEUTICALS] | 6 | Current NDC, Legacy NDC, 2 package rows | 20221027_8acce3c1-f4be-4968-a71f-3ffd9fbaa4a4.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 |
|---|
| 70436-019-82 | 70436001982 | 10 VIAL in 1 BOX (70436-019-82) / 5 mL in 1 VIAL | 10 vial | 2018-12-19 | 0000-00-00 | No | No | Current |