Ketorolac Tromethamine

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

American Health Packaging

DUNS Number

929561009

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

60687-104

Application Number

ANDA074754

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 13, 2022

Ingredients

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7FClass: IACT

HYPROMELLOSE 2910 (50 MPA.S)Inactive

Code: 1IVH67816NClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Code: 4EVE5946BQClass: ACTIBQuantity: 10 mg in 1 1