Azithromycin Dihydrate
- Product NDC
- 72789-483
- 11-digit product format
- 727890483
- Labeler code
- 72789
- Product ID
- 72789-483_512bfbd4-c1a2-5a2d-e063-6394a90ac176
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA208250
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- 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 Dihydrate
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-483-02 | Azithromycin Dihydrate | 2 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 2 | | 4 |
| 72789-483-04 | Azithromycin Dihydrate | 4 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 4 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-483 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 2 | Current NDC, 2 package rows | 20250124_7ab854bf-eb04-42c4-a403-096b60581bb4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-483-02 | 72789048302 | 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-483-02) | 2026-05-06 | No | No | Historical |
| 72789-483-04 | 72789048304 | 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-483-04) | 2025-01-22 | No | No | Historical |