Clarithromycin
- Product NDC
- 57237-045
- 11-digit product format
- 572370045
- Labeler code
- 57237
- Product ID
- 57237-045_ce30a7ce-c4f2-41b3-966d-c79fab80f76b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clarithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA065489
- Marketing category
- ANDA
- Marketing start
- 2012-07-25
- 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 |
|---|
| 57237-045-60 | Clarithromycin | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CLARITHROMYCIN | ACTIVE INGREDIENT | H1250JIK0A | CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| CLARITHROMYCIN | ACTIVE MOIETY | H1250JIK0A | CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
| VANILLIN | INACTIVE INGREDIENT | CHI530446X | CLARITHROMYCIN TABLET, FILM COATED [CITRON PHARMA LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57237-045 | CLARITHROMYCIN TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] | 17 | Current NDC, Legacy NDC, 1 package rows | 20240119_0c4db97f-f4c9-4cac-9f12-9db1d967ebeb.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 |
|---|
| 57237-045-60 | 57237004560 | 60 TABLET, FILM COATED in 1 BOTTLE (57237-045-60) | 2012-07-25 | 0000-00-00 | No | No | Current |