Azithromycin
- Product NDC
- 54348-854
- 11-digit product format
- 543480854
- Labeler code
- 54348
- Product ID
- 54348-854_8f76c314-24a0-1662-e053-2995a90ac764
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZITHROMYCIN ANHYDROUS
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PharmPak, Inc.
- Application
- ANDA065211
- Marketing category
- ANDA
- Marketing start
- 2019-07-10
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54348-854-00 | 54348085400 | 1 BOTTLE in 1 BOX (54348-854-00) > 1 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2019-07-10 | 0000-00-00 | No | No | Current |
| 54348-854-04 | 54348085404 | 1 BOTTLE in 1 BOX (54348-854-04) > 4 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2019-07-10 | 0000-00-00 | No | No | Current |