Azithromycin Dihydrate
- Product NDC
- 71093-174
- 11-digit product format
- 710930174
- Labeler code
- 71093
- Product ID
- 71093-174_5df20b25-1932-414b-b028-210e839c1c38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ACI Healthcare USA, Inc.
- Application
- ANDA215772
- Marketing category
- ANDA
- Marketing start
- 2022-12-01
- 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 Dihydrate
- 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 |
|---|
| 71093-174-01 | Azithromycin Dihydrate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71093-174 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [ACI HEALTHCARE USA, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231213_39a808c4-72ac-48e4-bfb8-e5ae3429b225.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 |
|---|
| 71093-174-01 | 71093017401 | 30 TABLET, FILM COATED in 1 BOTTLE (71093-174-01) | 2022-12-01 | 0000-00-00 | No | No | Current |