Clarithromycin
- Product NDC
- 72189-639
- 11-digit product format
- 721890639
- Labeler code
- 72189
- Product ID
- 72189-639_3e4be100-cd38-4560-e063-6294a90a9328
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clarithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA065489
- Marketing category
- ANDA
- Marketing start
- 2025-08-05
- Substance
- CLARITHROMYCIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clarithromycin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLARITHROMYCIN | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H1250JIK0A |
| Rxcui | 197517 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-639-10 | Clarithromycin | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 2 |
| 72189-639-20 | Clarithromycin | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-639-10 | 72189063910 | 10 TABLET, FILM COATED in 1 BOTTLE (72189-639-10) | 2025-08-05 | No | No | Current |
| 72189-639-20 | 72189063920 | 20 TABLET, FILM COATED in 1 BOTTLE (72189-639-20) | 2025-08-05 | No | No | Current |