Azithromycin
- Product NDC
- 68788-8702
- 11-digit product format
- 687888702
- Labeler code
- 68788
- Product ID
- 68788-8702_7086077c-81fd-496f-90ad-eaf4954ea70a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA207370
- Marketing category
- ANDA
- Marketing start
- 2024-06-27
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azithromycin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN DIHYDRATE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 308460, 749783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8702-6 | Azithromycin | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 4 |
| 68788-8702-6 | Azithromycin | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8702 | AZITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, 2 package rows | 20250104_4eec460d-5ba8-4614-8700-219a9b4fc385.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 |
|---|
| 68788-8702-6 | 68788870206 | 1 BLISTER PACK in 1 CARTON (68788-8702-6) / 6 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2024-06-27 | No | No | Historical |