AZITHROMYCIN
- Product NDC
- 33261-403
- 11-digit product format
- 332610403
- Labeler code
- 33261
- Product ID
- 33261-403_335dec43-2c8b-4432-81e1-f9284a7a834f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZITHROMYCIN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA065404
- Marketing category
- ANDA
- Marketing start
- 2008-02-11
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN ANHYDROUS
- Active strength
- 250 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC],Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401 | Product name | 9 | 20200616 |
| a2cbe82e-b432-4f71-954b-75e9214e8567 | Product name | 3 | 20200612 |
| 371533fa-efb3-4c48-b5e4-60179db407f3 | Product name | 3 | 20190124 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 33261-403-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ccfd-f424-e053-dadaa90a57ce | AZITHROMYCIN 250MG AND 500MG TAB 6 PCK AND 3 PCK FOR WOCKHARDT |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33261-403-01 | AZITHROMYCIN | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AZITHROMYCIN ANHYDROUS | ACTIVE INGREDIENT | J2KLZ20U1M | AZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| AZITHROMYCIN ANHYDROUS | ACTIVE MOIETY | J2KLZ20U1M | AZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 749780 | {3 (azithromycin 500 MG Oral Tablet) } Pack | GPCK | eeea2ed3-ae33-4e88-abdf-dfcf85582d46 | 1 |
| 749783 | {6 (azithromycin 250 MG Oral Tablet) } Pack | GPCK | eeea2ed3-ae33-4e88-abdf-dfcf85582d46 | 1 |
| 308460 | azithromycin 250 MG Oral Tablet | PSN | eeea2ed3-ae33-4e88-abdf-dfcf85582d46 | 1 |
| 749783 | azithromycin 250 MG Oral Tablet 6 Count Pack | PSN | eeea2ed3-ae33-4e88-abdf-dfcf85582d46 | 1 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | eeea2ed3-ae33-4e88-abdf-dfcf85582d46 | 1 |
| 749780 | azithromycin 500 MG Oral Tablet 3 Count Pack | PSN | eeea2ed3-ae33-4e88-abdf-dfcf85582d46 | 1 |
| 308460 | azithromycin 250 MG Oral Tablet | SCD | eeea2ed3-ae33-4e88-abdf-dfcf85582d46 | 1 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | eeea2ed3-ae33-4e88-abdf-dfcf85582d46 | 1 |
| 749783 | azithromycin 250 MG Oral Tablet 6 Count Pack | SY | eeea2ed3-ae33-4e88-abdf-dfcf85582d46 | 1 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | eeea2ed3-ae33-4e88-abdf-dfcf85582d46 | 1 |
| 749780 | azithromycin 500 MG Oral Tablet 3 Count Pack | SY | eeea2ed3-ae33-4e88-abdf-dfcf85582d46 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 33261-403-01 | 33261040301 | 6 in 1 BLISTER PACK | Historical |