NDC 54092-257

Fosrenol

Lanthanum Carbonate

Fosrenol is a Oral Powder in the Human Prescription Drug category. It is labeled and distributed by Shire Us Manufacturing Inc.. The primary component is Lanthanum Carbonate.

• Product ID: 54092-257_02476a55-c4c2-4af4-8add-099667f82d68
• NDC: 54092-257
• Product Type: Human Prescription Drug
• Proprietary Name: Fosrenol
• Generic Name: Lanthanum Carbonate
• Dosage Form: Powder
• Route of Administration: ORAL
• Marketing Start Date: 2014-09-24
• Marketing Category: NDA / NDA
• Application Number: NDA204734
• Labeler Name: Shire US Manufacturing Inc.
• Substance Name: LANTHANUM CARBONATE
• Active Ingredient Strength: 1000 mg/1
• Pharm Classes: Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 54092-257-02

9 CARTON in 1 CARTON (54092-257-02) > 10 POWDER in 1 CARTON (54092-257-01)

• Marketing Start Date: 2014-09-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54092-257-02 [54092025702]

Fosrenol POWDER

• Marketing Category: NDA
• Application Number: NDA204734
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-24

NDC 54092-257-01 [54092025701]

Fosrenol POWDER

• Marketing Category: NDA
• Application Number: NDA204734
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-03-11

Drug Details

Active Ingredients

Ingredient	Strength
LANTHANUM CARBONATE	1000 mg/1

OpenFDA Data

• SPL SET ID: f10776b2-2c25-4343-aabe-68f302e5cb54
• Manufacturer:
  • Shire US Manufacturing Inc.
• UNII:
  • 490D9F069T
• RxNorm Concept Unique ID - RxCUI:
  • 542465
  • 602635
  • 603122
  • 603112
  • 477347
  • 1551881
  • 1551884
  • 1551886
  • 1551885
  • 642452

Pharmacological Class

• Phosphate Binder [EPC]
• Phosphate Chelating Activity [MoA]

NDC Crossover Matching brand name "Fosrenol" or generic name "Lanthanum Carbonate"

NDC	Brand Name	Generic Name
54092-252	Fosrenol	lanthanum carbonate
54092-253	Fosrenol	lanthanum carbonate
54092-254	Fosrenol	lanthanum carbonate
54092-256	Fosrenol	lanthanum carbonate
54092-257	Fosrenol	lanthanum carbonate
0093-5938	Lanthanum carbonate	Lanthanum carbonate
0093-5939	Lanthanum carbonate	Lanthanum carbonate
0093-5940	Lanthanum carbonate	Lanthanum carbonate
66993-422	Lanthanum carbonate	LANTHANUM CARBONATE
66993-423	Lanthanum carbonate	LANTHANUM CARBONATE
66993-424	Lanthanum carbonate	LANTHANUM CARBONATE
68180-819	Lanthanum Carbonate	Lanthanum Carbonate
68180-820	Lanthanum Carbonate	Lanthanum Carbonate
68180-821	Lanthanum Carbonate	Lanthanum Carbonate
69097-934	Lanthanum carbonate	LANTHANUM CARBONATE
69097-935	Lanthanum carbonate	LANTHANUM CARBONATE