Clarithromycin
- Product NDC
- 43063-752
- 11-digit product format
- 430630752
- Labeler code
- 43063
- Product ID
- 43063-752_414b6e4d-1cbe-49be-e063-6294a90ad88f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clarithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA203584
- Marketing category
- ANDA
- Marketing start
- 2019-11-23
- 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 |
|---|
| 43063-752-14 | Clarithromycin | 14 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 14 | | 23 |
| 43063-752-20 | Clarithromycin | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 23 |
| 43063-752-28 | Clarithromycin | 28 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 28 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-752 | CLARITHROMYCIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 22 | Current NDC, Legacy NDC, 3 package rows | 20240608_1cb8a78a-0f07-49e8-a23e-a77628006209.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 |
|---|
| 43063-752-14 | 43063075214 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-752-14) | 2019-11-23 | 0000-00-00 | No | No | Current |
| 43063-752-20 | 43063075220 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-752-20) | 2019-11-23 | 0000-00-00 | No | No | Current |
| 43063-752-28 | 43063075228 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-752-28) | 2019-11-23 | 0000-00-00 | No | No | Current |