NDC 55289-800

Lipitor

Atorvastatin Calcium Trihydrate

Lipitor is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Atorvastatin Calcium Trihydrate.

• Product ID: 55289-800_7ac9a01c-284e-2961-e053-2991aa0a7873
• NDC: 55289-800
• Product Type: Human Prescription Drug
• Proprietary Name: Lipitor
• Generic Name: Atorvastatin Calcium Trihydrate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1996-12-17
• Marketing Category: NDA / NDA
• Application Number: NDA020702
• Labeler Name: PD-Rx Pharmaceuticals, Inc.
• Substance Name: ATORVASTATIN CALCIUM TRIHYDRATE
• 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: 2019-12-31

Packaging

NDC 55289-800-30

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-800-30)

• Marketing Start Date: 2012-02-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55289-800-30 [55289080030]

Lipitor TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020702
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-02-29

Drug Details

Active Ingredients

Ingredient	Strength
ATORVASTATIN CALCIUM TRIHYDRATE	20 mg/1

OpenFDA Data

• SPL SET ID: 17a163ef-b349-4e32-bc8c-b02bac7f65d6
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • 48A5M73Z4Q
• RxNorm Concept Unique ID - RxCUI:
  • 617310
  • 617318
• UPC Code:
  • 0355289800309

Pharmacological Class

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

NDC Crossover Matching brand name "Lipitor" or generic name "Atorvastatin Calcium Trihydrate"

NDC	Brand Name	Generic Name
0071-0155	Lipitor	atorvastatin calcium
0071-0156	Lipitor	atorvastatin calcium
0071-0157	Lipitor	atorvastatin calcium
0071-0158	Lipitor	atorvastatin calcium
70518-0036	Lipitor	Lipitor
21695-255	Lipitor	Lipitor
49299-1090	LIPITOR	LIPITOR
49299-1091	LIPITOR	LIPITOR
49299-1092	LIPITOR	LIPITOR
49299-1093	LIPITOR	LIPITOR
55289-861	Lipitor	Lipitor
55289-870	Lipitor	Lipitor
55289-800	Lipitor	Lipitor
63629-1446	Lipitor	Lipitor
63629-6768	Lipitor	Lipitor
63629-1447	Lipitor	Lipitor
63629-6776	Lipitor	Lipitor
63629-6633	Lipitor	Lipitor