Zithromax
- Product NDC
- 0069-0400
- 11-digit product format
- 000690400
- Labeler code
- 0069
- Product ID
- 0069-0400_87b9089f-c9cd-41c9-9358-29f6e4014af6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin dihydrate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA050733
- Marketing category
- NDA
- Marketing start
- 2014-03-07
- 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
- Zithromax
- 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, 1668240 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0069-0400-01 | Zithromax | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 25 |
| 0069-0400-10 | Zithromax | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 25 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AZITHROMYCIN DIHYDRATE | ACTIVE INGREDIENT | 5FD1131I7S | ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 7 | |
| AZITHROMYCIN ANHYDROUS | ACTIVE MOIETY | J2KLZ20U1M | ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 7 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 7 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0069-0400 | ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 25 | Current NDC, Legacy NDC, 2 package rows | 20250212_8d24bacb-feff-4c6a-b8df-625e1435387a.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 |
|---|
| 0069-0400-01 | 00069040001 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 0069-0400-10 | 00069040010 | 10 VIAL in 1 CARTON (0069-0400-10) / 5 mL in 1 VIAL (0069-0400-01) | 10 vial | 2014-03-07 | 0000-00-00 | No | No | Current |