Clopidogrel bisulfate
- Product NDC
- 55111-196
- 11-digit product format
- 551110196
- Labeler code
- 55111
- Product ID
- 55111-196_7fbef39d-2dec-fb75-2e25-b6a3b2d656e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clopidogrel bisulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr.Reddy's Laboratories Limited
- Application
- ANDA076273
- Marketing category
- ANDA
- Marketing start
- 2012-05-17
- Marketing end
- 2026-12-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clopidogrel bisulfate
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 |
|---|
| 55111-196-01 | Clopidogrel bisulfate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 24 |
| 55111-196-05 | Clopidogrel bisulfate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 24 |
| 55111-196-30 | Clopidogrel bisulfate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 24 |
| 55111-196-90 | Clopidogrel bisulfate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 24 |
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 [DR.REDDY'S LABORATORIES LIMITED] | 12 | |
| Clopidogrel | ACTIVE MOIETY | A74586SNO7 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 12 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 12 | |
| colloidal silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 12 | |
| Croscarmellose Sodium | INACTIVE INGREDIENT | M28OL1HH48 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 12 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 12 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 12 | |
| Mannitol | INACTIVE INGREDIENT | 3OWL53L36A | CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 12 | |
| Polyethylene glycol 400 | INACTIVE INGREDIENT | B697894SGQ | CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 12 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 12 | |
| Clopidogrel bisulfate | ACTIVE INGREDIENT | 08I79HTP27 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| Clopidogrel bisulfate | ACTIVE INGREDIENT | 08I79HTP27 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| Clopidogrel | ACTIVE MOIETY | A74586SNO7 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| Clopidogrel | ACTIVE MOIETY | A74586SNO7 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| colloidal silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| polyethylene glycol 400 | INACTIVE INGREDIENT | B697894SGQ | CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | CLOPIDOGREL BISULFATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CLOPIDOGREL BISULFATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] | 2 | |
| 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 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 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 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-196 | CLOPIDOGREL BISULFATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 23 | Current NDC, Legacy NDC, 4 package rows | 20221029_b5aa951f-72de-bea1-98a2-a4085c64a361.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 |
|---|
| 55111-196-01 | 55111019601 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-196-01) | 2012-05-17 | 0000-00-00 | No | No | Current |
| 55111-196-05 | 55111019605 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-196-05) | 2012-05-17 | 2026-12-31 | No | No | Current |
| 55111-196-30 | 55111019630 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-196-30) | 2012-05-17 | 2026-09-30 | No | No | Current |
| 55111-196-90 | 55111019690 | 90 TABLET, FILM COATED in 1 BOTTLE (55111-196-90) | 2012-05-17 | 2026-12-31 | No | No | Current |