Azithromycin
- Product NDC
- 45865-536
- 11-digit product format
- 458650536
- Labeler code
- 45865
- Product ID
- 45865-536_1eb8084b-68e2-3178-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Medsource Pharmaceuticals
- Application
- ANDA065225
- Marketing category
- ANDA
- Marketing start
- 2006-01-06
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC],Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45865-536-06 | Azithromycin | 1 in 1 BOX | TABLET, FILM COATED | 1 | | 1 |
| 45865-536-06 | Azithromycin | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AZITHROMYCIN MONOHYDRATE | ACTIVE INGREDIENT | JTE4MNN1MD | AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| AZITHROMYCIN ANHYDROUS | ACTIVE MOIETY | J2KLZ20U1M | AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-536 | AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] | 1 | Legacy NDC, 2 package rows | 20150902_1eb8084b-68e1-3178-e054-00144ff88e88.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 |
|---|
| 45865-536-06 | 45865053606 | 1 BLISTER PACK in 1 BOX (45865-536-06) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2006-01-06 | 0000-00-00 | No | No | Current |