Clarithromycin
- Product NDC
- 65862-226
- 11-digit product format
- 658620226
- Labeler code
- 65862
- Product ID
- 65862-226_4bb3048c-0a75-4818-9be5-4c81cfe9649c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clarithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA065489
- Marketing category
- ANDA
- Marketing start
- 2012-07-25
- 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 | 197516, 197517 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-226-10 | Clarithromycin | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 21 |
| 65862-226-10 | Clarithromycin | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 21 |
| 65862-226-60 | Clarithromycin | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 21 |
| 65862-226-99 | Clarithromycin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 21 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-226 | CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 21 | Current NDC, Legacy NDC, 4 package rows | 20231122_9aaffb41-408c-4372-8fd5-1d649450c0e9.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 |
|---|
| 65862-226-10 | 65862022610 | 10 BLISTER PACK in 1 CARTON (65862-226-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2012-07-25 | 0000-00-00 | No | No | Current |
| 65862-226-15 | 65862022615 | 1500 TABLET, FILM COATED in 1 BAG (65862-226-15) | | 25-JUL-12 | | | | Current |
| 65862-226-60 | 65862022660 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-226-60) | | 2012-07-25 | 0000-00-00 | No | No | Current |
| 65862-226-99 | 65862022699 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-226-99) | | 2012-07-25 | 0000-00-00 | No | No | Current |