Azithromycin
- Product NDC
- 63187-169
- 11-digit product format
- 631870169
- Labeler code
- 63187
- Product ID
- 63187-169_9471b50f-3435-48b2-a04b-d18e4bca88dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA065211
- Marketing category
- ANDA
- Marketing start
- 2005-11-14
- 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AZITHROMYCIN MONOHYDRATE | ACTIVE INGREDIENT | JTE4MNN1MD | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| AZITHROMYCIN ANHYDROUS | ACTIVE MOIETY | J2KLZ20U1M | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-169 | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 5 | Legacy NDC | 20191121_1926be99-3b3e-45ff-a1b9-4eb31312dd57.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-169-06 | 63187016906 | 1 DOSE PACK in 1 CARTON (63187-169-06) > 6 TABLET, FILM COATED in 1 DOSE PACK | 1 dose pack | 2014-09-01 | 0000-00-00 | No | No | Current |