Azithromycin
- Product NDC
- 63187-093
- 11-digit product format
- 631870093
- Labeler code
- 63187
- Product ID
- 63187-093_9d10dacc-ad17-48ec-b037-94987b2c40bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA065246
- Marketing category
- ANDA
- Marketing start
- 2010-12-17
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 200 mg/5mL
- 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 | 200 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JTE4MNN1MD |
| Rxcui | 141963 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-093-15 | Azithromycin | 15 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 15 | | 6 |
| 63187-093-22 | Azithromycin | 22.5 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 22.5 | | 6 |
| 63187-093-30 | Azithromycin | 30 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 30 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AZITHROMYCIN MONOHYDRATE | ACTIVE INGREDIENT | JTE4MNN1MD | AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 3 | |
| AZITHROMYCIN ANHYDROUS | ACTIVE MOIETY | J2KLZ20U1M | AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 3 | |
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | INACTIVE INGREDIENT | 905HNO1SIH | AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 3 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 3 | |
| SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS | INACTIVE INGREDIENT | SX01TZO3QZ | AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 3 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-093 | AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240412_44134421-cb0b-4e85-a3c8-d58bdb476fad.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 |
|---|
| 63187-093-15 | 63187009315 | 15 mL in 1 BOTTLE (63187-093-15) | 15 ml | 2014-07-01 | 0000-00-00 | No | No | Current |
| 63187-093-22 | 63187009322 | 22.5 mL in 1 BOTTLE (63187-093-22) | 22.5 ml | 2024-04-03 | | No | No | Historical |
| 63187-093-30 | 63187009330 | 30 mL in 1 BOTTLE (63187-093-30) | 30 ml | 2014-07-01 | 0000-00-00 | No | No | Current |