AZITHROMYCIN
- Product NDC
- 72189-088
- 11-digit product format
- 721890088
- Labeler code
- 72189
- Product ID
- 72189-088_4d3a98e6-31e9-c271-e063-6394a90aa19e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZITHROMYCIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA210001
- Marketing category
- ANDA
- Marketing start
- 2020-06-18
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 500 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN DIHYDRATE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 248656, 308460, 749780, 749783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-088-02 | AZITHROMYCIN | 2 in 1 BOTTLE | TABLET, FILM COATED | 2 | | 7 |
| 72189-088-03 | AZITHROMYCIN | 3 in 1 BOTTLE | TABLET, FILM COATED | 3 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-088 | AZITHROMYCIN TABLET, FILM COATED AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [DIRECT RX] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241116_a5b4092d-ab72-f5d1-e053-2995a90ac582.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 |
|---|
| 72189-088-02 | 72189008802 | 2 TABLET, FILM COATED in 1 BOTTLE (72189-088-02) | 2020-06-18 | | No | No | Current |
| 72189-088-03 | 72189008803 | 3 TABLET, FILM COATED in 1 BOTTLE (72189-088-03) | 2020-06-18 | 0000-00-00 | No | No | Current |