Azithromycin Dihydrate
- Product NDC
- 82804-153
- 11-digit product format
- 828040153
- Labeler code
- 82804
- Product ID
- 82804-153_edecf20d-c681-418b-9c47-02fb32d2b3c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA208249
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- 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 Dihydrate
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82804-153-04 | Azithromycin Dihydrate | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-153 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | Current NDC, 1 package rows | 20241006_edecf20d-c681-418b-9c47-02fb32d2b3c0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-153-04 | 82804015304 | 4 TABLET, FILM COATED in 1 BOTTLE (82804-153-04) | 2024-09-25 | No | No | Current |