clarithromycin
- Product NDC
- 0591-2805
- 11-digit product format
- 005912805
- Labeler code
- 0591
- Product ID
- 0591-2805_d97b84fc-7e0b-4f73-804d-522c2448b058
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clarithromycin
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA065145
- Marketing category
- ANDA
- Marketing start
- 2014-02-27
- 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 | 359385 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-2805-60 | clarithromycin | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | | 37 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CLARITHROMYCIN | ACTIVE INGREDIENT | H1250JIK0A | CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 27 | |
| CLARITHROMYCIN | ACTIVE MOIETY | H1250JIK0A | CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 27 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 27 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 27 | |
| POLYETHYLENE GLYCOL 3000 | INACTIVE INGREDIENT | SA1B764746 | CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 27 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 27 | |
| SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS | INACTIVE INGREDIENT | KH7I04HPUU | CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 27 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 27 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 27 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 27 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2805 | CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 37 | Current NDC, Legacy NDC, 1 package rows | 20250411_d5be5f12-6392-4d7d-ab23-ebc205ac1a85.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 |
|---|
| 0591-2805-60 | 00591280560 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2805-60) | 2014-02-27 | 0000-00-00 | No | No | Current |