CLARITHROMYCIN
- Product NDC
- 62135-883
- 11-digit product format
- 621350883
- Labeler code
- 62135
- Product ID
- 62135-883_459c547f-8c37-1425-e063-6394a90a48e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CLARITHROMYCIN
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA208987
- Marketing category
- ANDA
- Marketing start
- 2019-09-10
- 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 | 359385 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-883-60 | CLARITHROMYCIN | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-883 | CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [CHARTWELL RX, LLC] | 1 | Current NDC, 1 package rows | 20240420_dea5bd78-7f93-4bc4-a2e4-1b021f5fe098.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-883-60 | 62135088360 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62135-883-60) | 2024-04-16 | No | No | Current |