Azithromycin
- Product NDC
- 0409-0144
- 11-digit product format
- 004090144
- Labeler code
- 0409
- Product ID
- 0409-0144_0daee3b8-efec-4ff2-aedf-87035563373f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZITHROMYCIN
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA065500
- Marketing category
- ANDA
- Marketing start
- 2009-06-26
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-0144-11 | Azithromycin | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | | 30 |
| 0409-0144-21 | Azithromycin | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 30 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AZITHROMYCIN MONOHYDRATE | ACTIVE INGREDIENT | JTE4MNN1MD | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 17 | |
| AZITHROMYCIN ANHYDROUS | ACTIVE MOIETY | J2KLZ20U1M | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 17 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 17 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 17 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-0144 | AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 30 | Current NDC, Legacy NDC, 2 package rows | 20250418_d2f4907f-b952-403b-229e-cc5b8327a773.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0409-0144-10 | 00409014410 | 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-0144-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0144-31) | 2011-12-30 | 0000-00-00 | No | No | Current |
| 0409-0144-11 | 00409014411 | 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-0144-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-0144-21) | 2009-06-26 | 0000-00-00 | No | No | Current |
| 0409-0144-21 | 00409014421 | 1 in 1 VIAL, SINGLE-DOSE | | | | | Historical |