NDC Code(s) : 51754-5060-1
Packager : Exela Pharma Sciences, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Betamethasone Sodium Phosphate and Betamethasone AcetateBetamethasone Sodium Phosphate and Betamethasone Acetate INJECTION, SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51754-5060
Route of Administration INTRAMUSCULAR, INTRA-ARTICULAR, SOFT TISSUE, INTRALESIONAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Betamethasone Sodium Phosphate(UNII: 7BK02SCL3W)
(Betamethasone - UNII:9842X06Q6M) 		Betamethasone3 mg in 1 mL
Betamethasone Acetate(UNII: TI05AO53L7)
(Betamethasone - UNII:9842X06Q6M) 		Betamethasone Acetate3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Phosphate, Dibasic, Dihydrate(UNII: 94255I6E2T)8.9 mg in 1 mL
Sodium Phosphate, Monobasic, Dihydrate(UNII: 5QWK665956)3.8 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:51754-5060-11 in 1 BOX 06/01/2021
15 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA014602 06/01/2021

LABELER - Exela Pharma Sciences, LLC(831274399)

REGISTRANT - Organon LLC(117494753)

PRINCIPAL DISPLAY PANEL

NDC 51754-5060-1
Rx Only

Betamethasone
Sodium Phosphate and
Betamethasone Acetate
Injectable Suspension, USP

30 mg */5 mL (6 mg*/mL)

For intramuscular,
intra-articular or soft tissue
administration, intralesional,
intrabursal, and intradermal use

Shake well before using.

5 mL Multiple-Dose Vial

EXELA
PHARMA SCIENCES

PRINCIPAL DISPLAY PANEL - 5 mL Vial Box

PRINCIPAL DISPLAY PANEL

Rx Only

NDC 51754-5060-1

Betamethasone
Sodium Phosphate and
Betamethasone Acetate
Injectable Suspension, USP

30 mg */5 mL (6 mg */mL)

For Intramuscular, intra-articular
or soft tissue administration,
intralesional, intrabursal,
and intradermal use

5 mL Multiple-Dose Vial

PRINCIPAL DISPLAY PANEL - 5 mL Vial Label