Azithromycin Dihydrate
- Product NDC
- 82804-182
- 11-digit product format
- 828040182
- Labeler code
- 82804
- Product ID
- 82804-182_a8e106cb-7245-45a5-9aad-bd624b1e011d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA208250
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- 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
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A208250-001 | AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET / ORAL | AB | | 2019-04-17 |
Therapeutic equivalence codes#
Application-product, TE code table| Application-product | TE code |
|---|
| A208250-001 | AB |
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 | 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 |
|---|
| 82804-182-06 | Azithromycin Dihydrate | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 1 |
| 82804-182-06 | Azithromycin Dihydrate | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-182 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | Current NDC, 2 package rows | 20250202_a8e106cb-7245-45a5-9aad-bd624b1e011d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-182-06 | 82804018206 | 1 BLISTER PACK in 1 CARTON (82804-182-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2025-01-20 | No | No | Current |