Clarithromycin
- Product NDC
- 0527-1931
- 11-digit product format
- 005271931
- Labeler code
- 0527
- Product ID
- 0527-1931_0a136962-d1f1-f728-e063-6394a90a01b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clarithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA203584
- Marketing category
- ANDA
- Marketing start
- 2019-11-23
- Substance
- CLARITHROMYCIN
- Active strength
- 250 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 | 250 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 |
|---|
| 0527-1931-06 | Clarithromycin | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0527-1931 | CLARITHROMYCIN TABLET, FILM COATED [LANNETT COMPANY, INC.] | 19 | Current NDC, Legacy NDC, 1 package rows | 20231115_9bf207c0-86eb-4f3b-92e7-f65f3fccd5a7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0527-1931-06 | 00527193106 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1931-06) | 2019-11-23 | 0000-00-00 | No | No | Current |