azithromycin dihydrate
- Product NDC
- 67046-1503
- 11-digit product format
- 670461503
- Labeler code
- 67046
- Product ID
- 67046-1503_2cc9449e-e4be-3667-e063-6294a90af6ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin dihydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA065400
- Marketing category
- ANDA
- Marketing start
- 2025-01-28
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 600 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 | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 204844 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-1503-3 | azithromycin dihydrate | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67046-1503 | AZITHROMYCIN DIHYDRATE TABLET [COUPLER LLC] | 1 | Current NDC, 1 package rows | 20250130_2cc93e72-95ce-965b-e063-6394a90a8917.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 |
|---|
| 67046-1503-3 | 67046150303 | 30 TABLET in 1 BLISTER PACK (67046-1503-3) | 30 tablet | 2025-01-28 | No | No | Current |