NDC 61919-701

ROSUVASTATIN CALCIUM

Rosuvastatin Calcium

ROSUVASTATIN CALCIUM is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Rosuvastatin Calcium.

• Product ID: 61919-701_874bd64a-5af9-221e-e053-2995a90a6f79
• NDC: 61919-701
• Product Type: Human Prescription Drug
• Proprietary Name: ROSUVASTATIN CALCIUM
• Generic Name: Rosuvastatin Calcium
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-04-24
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207616
• Labeler Name: DIRECT RX
• Substance Name: ROSUVASTATIN CALCIUM
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61919-701-20

20 TABLET, FILM COATED in 1 BOTTLE (61919-701-20)

• Marketing Start Date: 2019-04-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-701-30 [61919070130]

ROSUVASTATIN CALCIUM TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA207616
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-19

NDC 61919-701-20 [61919070120]

ROSUVASTATIN CALCIUM TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA207616
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-04-24

NDC 61919-701-90 [61919070190]

ROSUVASTATIN CALCIUM TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA207616
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-08-19

Drug Details

Active Ingredients

Ingredient	Strength
ROSUVASTATIN CALCIUM	20 mg/1

OpenFDA Data

• SPL SET ID: 7a8db339-b98c-6fab-e053-2a91aa0a1247
• Manufacturer:
  • DIRECT RX
• UNII:
  • 83MVU38M7Q

Pharmacological Class

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

NDC Crossover Matching brand name "ROSUVASTATIN CALCIUM" or generic name "Rosuvastatin Calcium"

NDC	Brand Name	Generic Name
0093-7571	Rosuvastatin Calcium	Rosuvastatin Calcium
0093-7572	Rosuvastatin Calcium	Rosuvastatin Calcium
0093-7573	Rosuvastatin Calcium	Rosuvastatin Calcium
0378-2201	Rosuvastatin Calcium	rosuvastatin calcium
0378-2203	Rosuvastatin Calcium	rosuvastatin calcium
0378-2204	Rosuvastatin Calcium	rosuvastatin calcium
0378-2232	Rosuvastatin Calcium	rosuvastatin calcium
0781-5400	Rosuvastatin calcium	Rosuvastatin calcium
67877-440	Rosuvastatin Calcium	Rosuvastatin Calcium
67877-439	Rosuvastatin Calcium	Rosuvastatin Calcium
67877-441	Rosuvastatin Calcium	Rosuvastatin Calcium
67877-442	Rosuvastatin Calcium	Rosuvastatin Calcium
68071-3349	Rosuvastatin Calcium	Rosuvastatin Calcium
68071-3348	Rosuvastatin Calcium	Rosuvastatin Calcium
68071-4765	Rosuvastatin calcium	Rosuvastatin calcium
68071-4764	Rosuvastatin Calcium	Rosuvastatin Calcium
68180-731	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM
68180-730	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM
68180-732	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM
68180-733	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM
68462-262	Rosuvastatin Calcium	Rosuvastatin Calcium
68462-263	Rosuvastatin Calcium	Rosuvastatin Calcium
68462-264	Rosuvastatin Calcium	Rosuvastatin Calcium
68462-261	Rosuvastatin Calcium	Rosuvastatin Calcium
68788-7310	Rosuvastatin Calcium	Rosuvastatin Calcium
68788-6823	Rosuvastatin Calcium	Rosuvastatin Calcium
68788-7086	Rosuvastatin calcium	Rosuvastatin calcium
68788-6955	Rosuvastatin calcium	Rosuvastatin calcium
69539-007	Rosuvastatin Calcium	Rosuvastatin Calcium
69539-008	Rosuvastatin Calcium	Rosuvastatin Calcium
69539-009	Rosuvastatin Calcium	Rosuvastatin Calcium
69539-010	Rosuvastatin Calcium	Rosuvastatin Calcium
70377-007	Rosuvastatin calcium	Rosuvastatin calcium
70377-006	Rosuvastatin Calcium	Rosuvastatin Calcium
70377-008	Rosuvastatin calcium	Rosuvastatin calcium
70518-0002	Rosuvastatin Calcium	Rosuvastatin Calcium
70377-009	Rosuvastatin calcium	Rosuvastatin calcium
70518-0404	Rosuvastatin calcium	Rosuvastatin calcium
70518-0484	Rosuvastatin calcium	Rosuvastatin calcium
70518-0375	Rosuvastatin calcium	Rosuvastatin calcium
70518-0167	Rosuvastatin Calcium	Rosuvastatin Calcium
70518-1169	Rosuvastatin calcium	Rosuvastatin calcium
70518-0933	Rosuvastatin calcium	Rosuvastatin calcium
70518-0963	Rosuvastatin calcium	Rosuvastatin calcium
70518-0987	Rosuvastatin Calcium	Rosuvastatin Calcium
70518-1311	Rosuvastatin calcium	Rosuvastatin calcium
70518-1444	Rosuvastatin Calcium	Rosuvastatin Calcium
70518-1745	Rosuvastatin calcium	Rosuvastatin calcium
70518-1819	Rosuvastatin Calcium	Rosuvastatin Calcium
70518-1726	Rosuvastatin Calcium	Rosuvastatin Calcium