Azithromycin
- Product NDC
- 0781-8091
- 11-digit product format
- 007818091
- Labeler code
- 0781
- Product ID
- 0781-8091_5cec3961-a2a4-4f61-a73e-1656021b4195
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA065209
- Marketing category
- ANDA
- Marketing start
- 2005-11-14
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 600 mg/1
- 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 | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 204844 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0781-8091-31 | Azithromycin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-8091 | AZITHROMYCIN TABLET, FILM COATED [SANDOZ INC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20220205_34b70c23-92a6-460f-8dbb-15a0e6b9d3a9.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 |
|---|
| 0781-8091-31 | 00781809131 | 30 TABLET, FILM COATED in 1 BOTTLE (0781-8091-31) | 2019-02-14 | 0000-00-00 | No | No | Current |