Azithromycin
- Product NDC
- 63187-189
- 11-digit product format
- 631870189
- Labeler code
- 63187
- Product ID
- 63187-189_d6250595-3500-4c6f-8175-25a8a92e2d5e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA065223
- Marketing category
- ANDA
- Marketing start
- 2006-01-06
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azithromycin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN MONOHYDRATE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JTE4MNN1MD |
| Rxcui | 248656, 308460, 749783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-189-03 | Azithromycin | 3 in 1 BLISTER PACK | TABLET, FILM COATED | 3 | | 8 |
| 63187-189-03 | Azithromycin | 1 in 1 BOX | TABLET, FILM COATED | 1 | | 8 |
| 63187-189-04 | Azithromycin | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | | 8 |
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 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 2 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | 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 |
|---|
| 63187-189 | AZITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 8 | Current NDC, Legacy NDC, 3 package rows | 20220927_7e7c2f49-449c-4ba2-98ae-0ff0c040614c.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 |
|---|
| 63187-189-03 | 63187018903 | 1 BLISTER PACK in 1 BOX (63187-189-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2014-10-01 | 0000-00-00 | No | No | Current |
| 63187-189-04 | 63187018904 | 4 TABLET, FILM COATED in 1 BOTTLE (63187-189-04) | | 2022-09-14 | 0000-00-00 | No | No | Current |