Azithromycin Dihydrate
- Product NDC
- 71093-175
- 11-digit product format
- 710930175
- Labeler code
- 71093
- Product ID
- 71093-175_77a7e874-29c3-449c-92b3-448023e67197
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ACI Healthcare USA, Inc.
- Application
- ANDA215773
- Marketing category
- ANDA
- Marketing start
- 2023-07-30
- 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 |
|---|
| 71093-175-01 | Azithromycin Dihydrate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 71093-175-05 | Azithromycin Dihydrate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71093-175 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [ACI HEALTHCARE USA, INC.] | 6 | Current NDC, 2 package rows | 20231213_fb2f83a2-507b-4cf3-81ea-d10c46c0f8ea.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71093-175-01 | 71093017501 | 30 TABLET, FILM COATED in 1 BOTTLE (71093-175-01) | 2023-09-30 | No | No | Current |
| 71093-175-05 | 71093017505 | 500 TABLET, FILM COATED in 1 BOTTLE (71093-175-05) | 2023-09-30 | No | No | Current |