Azithromycin
- Product NDC
- 46708-057
- 11-digit product format
- 467080057
- Labeler code
- 46708
- Product ID
- 46708-057_bb31fbb2-b157-4333-ac3b-5f3d65039890
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA211791
- Marketing category
- ANDA
- Marketing start
- 2020-01-29
- 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 | 308460, 749783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46708-057-06 | Azithromycin | 18 in 1 CARTON | TABLET, FILM COATED | 18 | | 2 |
| 46708-057-06 | Azithromycin | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 2 |
| 46708-057-18 | Azithromycin | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 2 |
| 46708-057-18 | Azithromycin | 18 in 1 CARTON | TABLET, FILM COATED | 18 | | 2 |
| 46708-057-30 | Azithromycin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-057 | AZITHROMYCIN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 2 | Current NDC, Legacy NDC, 5 package rows | 20230113_deea1a56-84ed-4ce4-9d11-03271510c0a1.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 |
|---|
| 46708-057-06 | 46708005706 | 18 BLISTER PACK in 1 CARTON (46708-057-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK | 18 blister pack | 2020-01-29 | 0000-00-00 | No | No | Current |
| 46708-057-18 | 46708005718 | 18 BLISTER PACK in 1 CARTON (46708-057-18) / 6 TABLET, FILM COATED in 1 BLISTER PACK | 18 blister pack | 2020-01-29 | 0000-00-00 | No | No | Current |
| 46708-057-30 | 46708005730 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-057-30) | | 2020-01-29 | 0000-00-00 | No | No | Current |