NDC 68382-627

Rosuvastatin

Rosuvastatin

Rosuvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Rosuvastatin Calcium.

Product ID68382-627_0d5c4e98-9fd5-4f20-a852-948eb94d6334
NDC68382-627
Product TypeHuman Prescription Drug
Proprietary NameRosuvastatin
Generic NameRosuvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-01-16
Marketing CategoryANDA / ANDA
Application NumberANDA206513
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameROSUVASTATIN CALCIUM
Active Ingredient Strength5 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68382-627-01

100 TABLET, FILM COATED in 1 BOTTLE (68382-627-01)
Marketing Start Date2020-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-627-77 [68382062777]

Rosuvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206513
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-16

NDC 68382-627-16 [68382062716]

Rosuvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206513
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-16

NDC 68382-627-06 [68382062706]

Rosuvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206513
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-16

NDC 68382-627-01 [68382062701]

Rosuvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206513
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-16

NDC 68382-627-30 [68382062730]

Rosuvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206513
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-16

NDC 68382-627-10 [68382062710]

Rosuvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206513
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-16

NDC 68382-627-05 [68382062705]

Rosuvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206513
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-16

Drug Details

Active Ingredients

IngredientStrength
ROSUVASTATIN CALCIUM5 mg/1

Pharmacological Class

  • HMG-CoA Reductase Inhibitor [EPC]
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

NDC Crossover Matching brand name "Rosuvastatin" or generic name "Rosuvastatin"

NDCBrand NameGeneric Name
16729-284RosuvastatinRosuvastatin
16729-285RosuvastatinRosuvastatin
16729-286RosuvastatinRosuvastatin
16729-287RosuvastatinRosuvastatin
31722-882RosuvastatinRosuvastatin
31722-883RosuvastatinRosuvastatin
31722-884RosuvastatinRosuvastatin
31722-885RosuvastatinRosuvastatin
49252-061ROSUVASTATINrosuvastatin
49252-062ROSUVASTATINrosuvastatin
49252-063ROSUVASTATINrosuvastatin
49252-064ROSUVASTATINrosuvastatin
50090-2722RosuvastatinRosuvastatin
50090-2723RosuvastatinRosuvastatin
69238-1148RosuvastatinRosuvastatin
69238-1146RosuvastatinRosuvastatin
69238-1147RosuvastatinRosuvastatin
69238-1149RosuvastatinRosuvastatin
70518-0986RosuvastatinRosuvastatin
70518-1219RosuvastatinRosuvastatin
70518-1601RosuvastatinRosuvastatin
70518-1384RosuvastatinRosuvastatin
71205-044RosuvastatinRosuvastatin
50090-2724RosuvastatinRosuvastatin
50090-2725RosuvastatinRosuvastatin
50268-711RosuvastatinRosuvastatin
50268-709RosuvastatinRosuvastatin
50268-710RosuvastatinRosuvastatin
55700-574RosuvastatinRosuvastatin
55700-575RosuvastatinRosuvastatin
60505-2886ROSUVASTATINROSUVASTATIN
60505-4505ROSUVASTATINROSUVASTATIN
60505-2885ROSUVASTATINROSUVASTATIN
60505-4504ROSUVASTATINROSUVASTATIN
60505-2888ROSUVASTATINROSUVASTATIN
60505-2887ROSUVASTATINROSUVASTATIN
60505-4503ROSUVASTATINROSUVASTATIN
60505-4502ROSUVASTATINROSUVASTATIN
61919-786RosuvastatinRosuvastatin
50228-116RosuvastatinRosuvastatin
50228-117RosuvastatinRosuvastatin
50228-119RosuvastatinRosuvastatin
50228-118RosuvastatinRosuvastatin
47335-984EZALLOR SPRINKLEROSUVASTATIN
47335-985EZALLOR SPRINKLEROSUVASTATIN
47335-986EZALLOR SPRINKLEROSUVASTATIN
47335-987EZALLOR SPRINKLEROSUVASTATIN
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