Clarithromycin
- Product NDC
- 63304-822
- 11-digit product format
- 633040822
- Labeler code
- 63304
- Product ID
- 63304-822_1cf704dd-e3e3-4ae6-9b3e-f67116212adc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clarithromycin
- Dosage form
- GRANULE, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Ranbaxy Pharmaceuticals Inc.
- Application
- ANDA065382
- Marketing category
- ANDA
- Marketing start
- 2007-10-03
- Marketing end
- 0000-00-00
- Substance
- CLARITHROMYCIN
- Active strength
- 250 mg/5mL
- Pharmacologic classes
- Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-822-03 | Clarithromycin | 50 mL in 1 BOTTLE | GRANULE, FOR SUSPENSION | 50 | | 4 |
| 63304-822-04 | Clarithromycin | 100 mL in 1 BOTTLE | GRANULE, FOR SUSPENSION | 100 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CLARITHROMYCIN | ACTIVE INGREDIENT | H1250JIK0A | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| CLARITHROMYCIN | ACTIVE MOIETY | H1250JIK0A | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| ALGINIC ACID | INACTIVE INGREDIENT | 8C3Z4148WZ | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| CASTOR OIL | INACTIVE INGREDIENT | D5340Y2I9G | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) | INACTIVE INGREDIENT | 87Y6436BKR | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-822 | CLARITHROMYCIN TABLET, FILM COATED CLARITHROMYCIN GRANULE, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] | 4 | Legacy NDC, 2 package rows | 20131115_94c182ed-f2d6-4f7f-bdd9-69b136c54623.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 63304-822-03 | 63304082203 | 50 mL in 1 BOTTLE | 50 ml | Historical |
| 63304-822-04 | 63304082204 | 100 mL in 1 BOTTLE | 100 ml | Historical |