Ketorolac Tromethamine (Page 9 of 9)

DESCRIPTION

Ketorolac Tromethamine Tablets USP are a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine, USP is (±)-5-benzoyl-2,3-dihydro-1 H -pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). The structural formula is:

Structure
(click image for full-size original)

C 15 H 13 NO 3 . C 4 H 11 NO 3 M.W. 376.40

Ketorolac tromethamine, USP is a racemic mixture of [-]S and [+]R ketorolac tromethamine, USP. Ketorolac tromethamine, USP may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine, USP has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26.

Ketorolac Tromethamine Tablets USP are white, round, convex, unscored, film coated tablets. Each tablet, for oral administration, contains 10 mg ketorolac tromethamine, USP, the active ingredient. In addition, each tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.

Principal Display Panel

Ketorolac Tromethamine Tablets, USP 10mg
10 Tablets
NDC 10544-222-10

10mg 10ct
(click image for full-size original)

KETOROLAC TROMETHAMINE
ketorolac tromethamine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-222(NDC:0093-0314)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE (KETOROLAC) KETOROLAC TROMETHAMINE 10 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 93;314
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-222-10 10 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:10544-222-15 15 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:10544-222-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074754 07/15/2011
Labeler — Blenheim Pharmacal, Inc. (171434587)
Registrant — Blenheim Pharmacal, Inc. (171434587)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 repack (10544-222)

Revised: 06/2015 Blenheim Pharmacal, Inc.

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