lone acetonide injection, suspension
Product Information
Item Code (Source) NDC:0003-0293
Route of Administration INTRAMUSCULAR, INTRA-ARTICULAR
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA) TRIAMCINOLONE ACETONIDE 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
NITROGEN (UNII: N762921K75)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0003-0293-05 1 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA014901 06/01/2009
Part 3 of 4
AMMONIA
ammonia inhalant
Product Information
Item Code (Source) NDC:39822-9900
Route of Administration RESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA 0.045 g in 0.3 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL (UNII: 3K9958V90M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LAVENDER OIL (UNII: ZBP1YXW0H8)
WATER (UNII: 059QF0KO0R)
NUTMEG OIL (UNII: Z1CLM48948)
LEMON (UNII: 24RS0A988O)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:39822-9900-2 0.3 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/14/1976
Part 4 of 4
PVP IODINE PREP PAD MEDIUM AND LARGE
providone iodine swab
Product Information
Item Code (Source) NDC:10819-3883
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10819-3883-3 2.2 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 01/01/1978
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 05/30/2013
Labeler - Asclemed USA, Inc. (059888437)
Revised: 2/2016
Document Id: 5418 |
