Clarithromycin
- Product NDC
- 82804-141
- 11-digit product format
- 828040141
- Labeler code
- 82804
- Product ID
- 82804-141_aae34d8f-9c4b-472a-b117-7f9f778fd59c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clarithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clarithromycin
- Listing expiration
- 2027-12-31
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 |
|---|
| 82804-141-14 | Clarithromycin | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 3 |
| 82804-141-20 | Clarithromycin | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 3 |
| 82804-141-28 | Clarithromycin | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82804-141 | CLARITHROMYCIN TABLET, FILM COATED [PROFICIENT RX LP] | 1 | Current NDC, 3 package rows | 20240927_88c7ded8-333c-408d-b693-a72881710f59.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-141-14 | 82804014114 | 14 TABLET, FILM COATED in 1 BOTTLE (82804-141-14) | 2026-04-02 | No | No | Current |
| 82804-141-20 | 82804014120 | 20 TABLET, FILM COATED in 1 BOTTLE (82804-141-20) | 2026-02-19 | No | No | Current |
| 82804-141-28 | 82804014128 | 28 TABLET, FILM COATED in 1 BOTTLE (82804-141-28) | 2024-09-17 | No | No | Current |