Clarithromycin
- Product NDC
- 46708-345
- 11-digit product format
- 467080345
- Labeler code
- 46708
- Product ID
- 46708-345_17817dba-4183-4a14-a55f-3e1240ea03a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clarithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA210459
- Marketing category
- ANDA
- Marketing start
- 2022-02-01
- 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 |
|---|
| 46708-345-30 | Clarithromycin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 46708-345-60 | Clarithromycin | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 46708-345-91 | Clarithromycin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-345 | CLARITHROMYCIN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, 3 package rows | 20230531_268d21f9-02c9-41b0-9487-7968ea12720d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-345-30 | 46708034530 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-345-30) | 2022-02-01 | No | No | Current |
| 46708-345-60 | 46708034560 | 60 TABLET, FILM COATED in 1 BOTTLE (46708-345-60) | 2022-02-01 | No | No | Current |
| 46708-345-91 | 46708034591 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-345-91) | 2022-02-01 | No | No | Current |