azithromycin
- Product NDC
- 0527-2395
- 11-digit product format
- 005272395
- Labeler code
- 0527
- Product ID
- 0527-2395_371e26cf-af95-77d5-e063-6294a90a34b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZITHROMYCIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA209044
- Marketing category
- ANDA
- Marketing start
- 2019-07-04
- 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
- 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, 308460, 749780, 749783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0527-2395-19 | azithromycin | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 9 |
| 0527-2395-19 | azithromycin | 3 in 1 BLISTER PACK | TABLET, FILM COATED | 3 | | 9 |
| 0527-2395-32 | 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 |
|---|
| 0527-2395 | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) TABLET, FILM COATED [LANNETT COMPANY, INC.] | 8 | Current NDC, Legacy NDC, 3 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0527-2395-17 | 00527239517 | 3 TABLET, FILM COATED in 1 BLISTER PACK (0527-2395-17) | | 2020-02-11 | 0000-00-00 | No | No | Current |
| 0527-2395-19 | 00527239519 | 1 BLISTER PACK in 1 CARTON (0527-2395-19) / 3 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2019-07-04 | | No | No | Current |
| 0527-2395-32 | 00527239532 | 30 TABLET, FILM COATED in 1 BOTTLE (0527-2395-32) | | 2019-07-04 | 0000-00-00 | No | No | Current |
| 0527-2395-72 | 00527239572 | 3 TABLET, FILM COATED in 1 BLISTER PACK (0527-2395-72) | | 2020-02-11 | 0000-00-00 | No | No | Current |