Clopidogrel Bisulfate
- Product NDC
- 47335-894
- 11-digit product format
- 473350894
- Labeler code
- 47335
- Product ID
- 47335-894_2de2d0fb-68e7-4a22-8da8-be7658468f15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clopidogrel Bisulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090494
- Marketing category
- ANDA
- Marketing start
- 2012-05-18
- Substance
- CLOPIDOGREL BISULFATE
- Active strength
- 75 mg/1
- Pharmacologic classes
- Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clopidogrel Bisulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOPIDOGREL BISULFATE | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 08I79HTP27 |
| Rxcui | 309362 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-894-13 | Clopidogrel Bisulfate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 15 |
| 47335-894-18 | Clopidogrel Bisulfate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 15 |
| 47335-894-19 | Clopidogrel Bisulfate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 15 |
| 47335-894-81 | Clopidogrel Bisulfate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 15 |
| 47335-894-83 | Clopidogrel Bisulfate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CLOPIDOGREL BISULFATE | ACTIVE INGREDIENT | 08I79HTP27 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| CLOPIDOGREL | ACTIVE MOIETY | A74586SNO7 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | ZF94AP8MEY | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 5 | |
| CLOPIDOGREL BISULFATE | ACTIVE INGREDIENT | 08I79HTP27 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CLOPIDOGREL | ACTIVE MOIETY | A74586SNO7 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYDROGENATED CASTOR OIL | INACTIVE INGREDIENT | ZF94AP8MEY | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-894 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 15 | Current NDC, Legacy NDC, 5 package rows | 20221012_d37db064-3a5a-4a0c-a60b-b4b417fe742a.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 |
|---|
| 47335-894-13 | 47335089413 | 500 TABLET, FILM COATED in 1 BOTTLE (47335-894-13) | 2012-05-18 | 0000-00-00 | No | No | Current |
| 47335-894-18 | 47335089418 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-894-18) | 2012-05-18 | 0000-00-00 | No | No | Current |
| 47335-894-19 | 47335089419 | 90 TABLET, FILM COATED in 1 BOTTLE (47335-894-19) | 2012-05-18 | 0000-00-00 | No | No | Current |
| 47335-894-81 | 47335089481 | 90 TABLET, FILM COATED in 1 BOTTLE (47335-894-81) | 2012-05-18 | 0000-00-00 | No | No | Current |
| 47335-894-83 | 47335089483 | 30 TABLET, FILM COATED in 1 BOTTLE (47335-894-83) | 2012-05-18 | 0000-00-00 | No | No | Current |