azithromycin
- Product NDC
- 0904-7351
- 11-digit product format
- 009047351
- Labeler code
- 0904
- Product ID
- 0904-7351_7cae275e-abb8-4fad-af20-fa3fdbf095e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA065399
- Marketing category
- ANDA
- Marketing start
- 2023-05-01
- Substance
- AZITHROMYCIN DIHYDRATE
- 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
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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 248656, 308460 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-7351-04 | azithromycin | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 5 |
| 0904-7351-04 | azithromycin | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7351 | AZITHROMYCIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 4 | Current NDC, 2 package rows | 20250514_814abe38-da4a-48af-bf4b-2ce04a5aabd1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7351-04 | 00904735104 | 30 BLISTER PACK in 1 CARTON (0904-7351-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 30 blister pack | 2023-05-01 | No | No | Current |