AZITHROMYCIN MONOHYDRATE
- Product NDC
- 61919-260
- 11-digit product format
- 619190260
- Labeler code
- 61919
- Product ID
- 61919-260_3479aa8c-e9af-4f68-9bc9-6436f38890c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZITHROMYCIN MONOHYDRATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA065225
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC],Macrolides [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 61919-260-06 | AZITHROMYCIN MONOHYDRATE | 06 in 1 BOTTLE | TABLET, FILM COATED | 06 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AZITHROMYCIN MONOHYDRATE | ACTIVE INGREDIENT | JTE4MNN1MD | AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX] | 5 | |
| AZITHROMYCIN ANHYDROUS | ACTIVE MOIETY | J2KLZ20U1M | AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX] | 5 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX] | 5 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX] | 5 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX] | 5 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-260 | AZITHROMYCIN MONOHYDRATE TABLET, FILM COATED [DIRECT RX] | 5 | Legacy NDC, 1 package rows | 20150512_884d8dfb-980a-4bf9-aacd-7eba6373315b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 61919-260-06 | 61919026006 | 06 in 1 BOTTLE | Historical |