Azithromycin
- Product NDC
- 68071-4812
- 11-digit product format
- 680714812
- Labeler code
- 68071
- Product ID
- 68071-4812_2d0644a1-e698-e6a7-e063-6394a90a3623
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA207370
- Marketing category
- ANDA
- Marketing start
- 2018-07-05
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 250 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 | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 308460 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4812-2 | Azithromycin | 2 in 1 BOTTLE | TABLET, FILM COATED | 2 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4812 | AZITHROMYCIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20250202_a9cdb5ae-2aeb-c598-e053-2a95a90a8062.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 |
|---|
| 68071-4812-2 | 68071481202 | 2 TABLET, FILM COATED in 1 BOTTLE (68071-4812-2) | 2025-01-31 | | No | No | Historical |
| 68071-4812-4 | 68071481204 | 4 TABLET, FILM COATED in 1 BOTTLE (68071-4812-4) | 2020-07-06 | 0000-00-00 | No | No | Current |