NDC Code(s) : 49349-757-57
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CELESTONE SOLUSPANBetamethasone Acetate and Betamethasone Sodium Phosphate INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-757(NDC:0085-0566)
Route of Administration INTRA-ARTICULAR, INTRAMUSCULAR, SOFT TISSUE, INTRALESIONAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETAMETHASONE ACETATE(UNII: TI05AO53L7)
(BETAMETHASONE - UNII:9842X06Q6M) 		BETAMETHASONE ACETATE3 mg in 1 mL
BETAMETHASONE SODIUM PHOSPHATE(UNII: 7BK02SCL3W)
(BETAMETHASONE - UNII:9842X06Q6M) 		BETAMETHASONE3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC(UNII: GR686LBA74)7.1 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC(UNII: 3980JIH2SW)3.4 mg in 1 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)0.1 mg in 1 mL
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)0.2 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-757-575 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product07/05/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA014602 05/07/2015 08/02/2016

PRINCIPAL DISPLAY PANEL

DRUG: CELESTONE SOLUSPAN

GENERIC: Betamethasone Acetate and Betamethasone Sodium Phosphate

DOSAGE: INJECTION, SUSPENSION

ADMINSTRATION: INTRAMUSCULAR

NDC: 49349-757-57

PACKAGING: 5 mL in 1 BOX

ACTIVE INGREDIENT(S):

  • Betamethasone Acetate 3mg in 1mL
  • Betamethasone Sodium Phosphate 3mg in 1mL

INACTIVE INGREDIENT(S):

  • Benzalkonium Chloride
  • Edetate Disodium
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic

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