NDC 0085-4320

CELESTONE SOLUSPAN

Betamethasone Acetate And Betamethasone Sodium Phosphate

CELESTONE SOLUSPAN is a Intra-articular; Intralesional; Intramuscular; Soft Tissue Injection, Suspension in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Betamethasone Acetate; Betamethasone Sodium Phosphate.

• Product ID: 0085-4320_21506ad3-4b4e-4052-b848-8620c428fcbc
• NDC: 0085-4320
• Product Type: Human Prescription Drug
• Proprietary Name: CELESTONE SOLUSPAN
• Generic Name: Betamethasone Acetate And Betamethasone Sodium Phosphate
• Dosage Form: Injection, Suspension
• Route of Administration: INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
• Marketing Start Date: 2017-03-02
• Marketing Category: NDA / NDA
• Application Number: NDA014602
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
• Active Ingredient Strength: 3 mg/mL; mg/mL
• Pharm Classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0085-4320-01

1 VIAL, MULTI-DOSE in 1 BOX (0085-4320-01) > 5 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2017-03-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0085-4320-01 [00085432001]

CELESTONE SOLUSPAN INJECTION, SUSPENSION

• Marketing Category: NDA
• Application Number: NDA014602
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-03-02

Drug Details

Active Ingredients

Ingredient	Strength
BETAMETHASONE ACETATE	3 mg/mL

OpenFDA Data

• SPL SET ID: 7b5489a1-e30f-450f-bd2b-00d05fd52915
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • TI05AO53L7
  • 7BK02SCL3W
• RxNorm Concept Unique ID - RxCUI:
  • 578806
  • 578803

Pharmacological Class

• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]
• Corticosteroid [EPC]
• Corticosteroid Hormone Receptor Agonists [MoA]

NDC Crossover Matching brand name "CELESTONE SOLUSPAN" or generic name "Betamethasone Acetate And Betamethasone Sodium Phosphate"

NDC	Brand Name	Generic Name
0085-4320	CELESTONE SOLUSPAN	Betamethasone Acetate and Betamethasone Sodium Phosphate
70518-1879	CELESTONE SOLUSPAN	Betamethasone Acetate and Betamethasone Sodium Phosphate
78206-118	CELESTONE SOLUSPAN	Betamethasone Acetate and Betamethasone Sodium Phosphate