NDC 47335-984

EZALLOR SPRINKLE

Rosuvastatin

EZALLOR SPRINKLE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Rosuvastatin Calcium.

• Product ID: 47335-984_4715d68e-17c6-4791-8311-066edc291fb3
• NDC: 47335-984
• Product Type: Human Prescription Drug
• Proprietary Name: EZALLOR SPRINKLE
• Generic Name: Rosuvastatin
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-04
• Marketing Category: NDA / NDA
• Application Number: NDA208647
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: ROSUVASTATIN CALCIUM
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 47335-984-64

3 BLISTER PACK in 1 CARTON (47335-984-64) > 10 CAPSULE in 1 BLISTER PACK (47335-984-60)

• Marketing Start Date: 2019-05-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 47335-984-81 [47335098481]

EZALLOR SPRINKLE CAPSULE

• Marketing Category: NDA
• Application Number: NDA208647
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-04

NDC 47335-984-64 [47335098464]

EZALLOR SPRINKLE CAPSULE

• Marketing Category: NDA
• Application Number: NDA208647
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-04

NDC 47335-984-83 [47335098483]

EZALLOR SPRINKLE CAPSULE

• Marketing Category: NDA
• Application Number: NDA208647
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-04

NDC 47335-984-60 [47335098460]

EZALLOR SPRINKLE CAPSULE

• Marketing Category: NDA
• Application Number: NDA208647
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-04

Drug Details

Active Ingredients

Ingredient	Strength
ROSUVASTATIN CALCIUM	5 mg/1

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
47335-984	EZALLOR SPRINKLE	ROSUVASTATIN
47335-985	EZALLOR SPRINKLE	ROSUVASTATIN
47335-986	EZALLOR SPRINKLE	ROSUVASTATIN
47335-987	EZALLOR SPRINKLE	ROSUVASTATIN
16729-284	Rosuvastatin	Rosuvastatin
16729-285	Rosuvastatin	Rosuvastatin
16729-286	Rosuvastatin	Rosuvastatin
16729-287	Rosuvastatin	Rosuvastatin
31722-882	Rosuvastatin	Rosuvastatin
31722-883	Rosuvastatin	Rosuvastatin
31722-884	Rosuvastatin	Rosuvastatin
31722-885	Rosuvastatin	Rosuvastatin
49252-061	ROSUVASTATIN	rosuvastatin
49252-062	ROSUVASTATIN	rosuvastatin
49252-063	ROSUVASTATIN	rosuvastatin
49252-064	ROSUVASTATIN	rosuvastatin
50090-2722	Rosuvastatin	Rosuvastatin
50090-2723	Rosuvastatin	Rosuvastatin