Clarithromycin
- Product NDC
- 68071-3116
- 11-digit product format
- 680713116
- Labeler code
- 68071
- Product ID
- 68071-3116_2abbae2e-2b8b-62d9-e063-6394a90a39b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clarithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA203584
- Marketing category
- ANDA
- Marketing start
- 2015-12-04
- 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 |
|---|
| 68071-3116-2 | Clarithromycin | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 8 |
| 68071-3116-3 | Clarithromycin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 8 |
| 68071-3116-4 | Clarithromycin | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 8 |
| 68071-3116-8 | Clarithromycin | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3116 | CLARITHROMYCIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 4 package rows | 20250104_4a3febd5-8cf4-5306-e054-00144ff8d46c.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 |
|---|
| 68071-3116-2 | 68071311602 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-3116-2) | 2017-03-08 | 0000-00-00 | No | No | Current |
| 68071-3116-3 | 68071311603 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3116-3) | 2017-03-08 | 0000-00-00 | No | No | Current |
| 68071-3116-4 | 68071311604 | 14 TABLET, FILM COATED in 1 BOTTLE (68071-3116-4) | 2017-03-08 | 0000-00-00 | No | No | Current |
| 68071-3116-8 | 68071311608 | 28 TABLET, FILM COATED in 1 BOTTLE (68071-3116-8) | 2017-03-08 | 0000-00-00 | No | No | Current |