azithromycin
- Product NDC
- 0527-2370
- 11-digit product format
- 005272370
- Labeler code
- 0527
- Product ID
- 0527-2370_371e26cf-af95-77d5-e063-6294a90a34b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZITHROMYCIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA209045
- Marketing category
- ANDA
- Marketing start
- 2019-07-04
- 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
- 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 | 248656, 308460, 749780, 749783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0527-2370-20 | azithromycin | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 9 |
| 0527-2370-32 | azithromycin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-2370 | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) TABLET, FILM COATED [LANNETT COMPANY, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240314_a2b0c06b-e93d-f5aa-e053-2995a90ac9aa.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 |
|---|
| 0527-2370-20 | 00527237020 | 6 TABLET, FILM COATED in 1 BLISTER PACK (0527-2370-20) | 2024-10-22 | 0000-00-00 | No | No | Current |
| 0527-2370-32 | 00527237032 | 30 TABLET, FILM COATED in 1 BOTTLE (0527-2370-32) | 2019-07-04 | 0000-00-00 | No | No | Current |
| 0527-2370-72 | 00527237072 | 6 TABLET, FILM COATED in 1 BLISTER PACK (0527-2370-72) | 2020-02-11 | 0000-00-00 | No | No | Current |