Azithromycin
- Product NDC
- 62980-962
- 11-digit product format
- 629800962
- Labeler code
- 62980
- Product ID
- 62980-962_f6898322-3e70-4e68-820e-315ae41a4b36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Vivimed Labs Limited
- Application
- ANDA065302
- Marketing category
- ANDA
- Marketing start
- 2008-02-11
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN ANHYDROUS
- Active strength
- 600 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC],Macrolides [CS]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|
| 62980-962-01 | Azithromycin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 62980-962-03 | Azithromycin | 1400 in 1 POUCH | TABLET, FILM COATED | 1400 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AZITHROMYCIN ANHYDROUS | ACTIVE INGREDIENT | J2KLZ20U1M | AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED] | 1 | |
| AZITHROMYCIN ANHYDROUS | ACTIVE MOIETY | J2KLZ20U1M | AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED] | 1 | |
| MAGNESIUM TRISILICATE | INACTIVE INGREDIENT | C2E1CI501T | AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62980-962 | AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED] | 2 | Legacy NDC, 2 package rows | 20170925_bf0ed82e-6a7f-436c-9ee7-fd47b1c9fc3e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 62980-962-01 | 62980096201 | 30 in 1 BOTTLE | Historical |
| 62980-962-03 | 62980096203 | 1400 in 1 POUCH | Historical |