ketorolac tromethamine

Product NDC
72266-118
11-digit product format
722660118
Labeler code
72266
Product ID
72266-118_228ec94a-f777-f61b-e063-6394a90a21a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
FOSUN PHARMA USA INC
Application
ANDA204216
Marketing category
ANDA
Marketing start
2023-06-23
Substance
KETOROLAC TROMETHAMINE
Active strength
30 mg/mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ketorolac tromethamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72266-118-01ketorolac tromethamine1 mL in 1 VIALINJECTION, SOLUTION116
72266-118-25ketorolac tromethamine25 in 1 CARTONINJECTION, SOLUTION2516
72266-118-01Ketorocaine LM Kit1 mL in 1 VIALINJECTION, SOLUTION1 mL30 mg in 1mL14
72266-118-01Ketorocaine L Kit1 mL in 1 VIALINJECTION, SOLUTION1 mL30 mg in 1mL11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-118-01ML - Milliliter72266-118b2a7bfcf-b1bf-4514-b840-76b801c18c5912019-06-19
72266-118-25ML - Milliliter72266-118016fbe57-69a2-4dcf-8311-ec37db36efb312019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bupivacaine HydrochlorideACTIVE INGREDIENT7TQO7W3VT8KETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
Isopropyl AlcoholACTIVE INGREDIENTND2M416302KETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
Ketorolac TromethamineACTIVE INGREDIENT4EVE5946BQKETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41AKETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
Povidone-IodineACTIVE INGREDIENT85H0HZU99MKETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
BupivacaineACTIVE MOIETYY8335394ROKETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
IodineACTIVE MOIETY9679TC07X4KETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
Isopropyl AlcoholACTIVE MOIETYND2M416302KETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
KetorolacACTIVE MOIETYYZI5105V0LKETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
LidocaineACTIVE MOIETY98PI200987KETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MKETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBKETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
Nonoxynol-9INACTIVE INGREDIENT48Q180SH9TKETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XKETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IKETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RKETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]2
Isopropyl AlcoholACTIVE INGREDIENTND2M416302KETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Ketorolac TromethamineACTIVE INGREDIENT4EVE5946BQKETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41AKETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Povidone-IodineACTIVE INGREDIENT85H0HZU99MKETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
IodineACTIVE MOIETY9679TC07X4KETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Isopropyl AlcoholACTIVE MOIETYND2M416302KETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
KetorolacACTIVE MOIETYYZI5105V0LKETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
LidocaineACTIVE MOIETY98PI200987KETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MKETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBKETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Nonoxynol-9INACTIVE INGREDIENT48Q180SH9TKETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XKETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IKETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RKETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-118KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FOSUN PHARMA USA INC]16Current NDC, Legacy NDC, 2 package rows20250306_1aae6a4d-0909-4672-aa26-e3f2d8c4d413.zip
72266-118KETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]13Current NDC, Legacy NDC20241008_35ffe071-8bc1-4c88-8c85-645847acf169.zip
72266-118KETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]10Current NDC, Legacy NDC20241008_ee0d396c-5caa-4a1a-9865-1a742d9d8d68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSN1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCD1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
860092ketorolac tromethamine 15 MG per 1 ML InjectionSY1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN35ffe071-8bc1-4c88-8c85-645847acf16914
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSN35ffe071-8bc1-4c88-8c85-645847acf16914
797544isopropyl alcohol 70 % Medicated PadPSN35ffe071-8bc1-4c88-8c85-645847acf16914
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN35ffe071-8bc1-4c88-8c85-645847acf16914
1737568lidocaine HCl 1 % in 2 ML InjectionPSN35ffe071-8bc1-4c88-8c85-645847acf16914
797730povidone-iodine 10 % Medicated PadPSN35ffe071-8bc1-4c88-8c85-645847acf16914
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD35ffe071-8bc1-4c88-8c85-645847acf16914
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD35ffe071-8bc1-4c88-8c85-645847acf16914
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCD35ffe071-8bc1-4c88-8c85-645847acf16914
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD35ffe071-8bc1-4c88-8c85-645847acf16914
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD35ffe071-8bc1-4c88-8c85-645847acf16914
797730povidone-iodine 100 MG/ML Medicated PadSCD35ffe071-8bc1-4c88-8c85-645847acf16914
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY35ffe071-8bc1-4c88-8c85-645847acf16914
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSY35ffe071-8bc1-4c88-8c85-645847acf16914
797544isopropyl alcohol 70 % Medicated PadSY35ffe071-8bc1-4c88-8c85-645847acf16914
797544isopropyl alcohol 70 % Topical ClothSY35ffe071-8bc1-4c88-8c85-645847acf16914
797544isopropyl alcohol 70 % Topical SwabSY35ffe071-8bc1-4c88-8c85-645847acf16914
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY35ffe071-8bc1-4c88-8c85-645847acf16914
1737568lidocaine HCl 1 % per 2 ML InjectionSY35ffe071-8bc1-4c88-8c85-645847acf16914
1737568lidocaine HCl 20 MG per 2 ML InjectionSY35ffe071-8bc1-4c88-8c85-645847acf16914
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY35ffe071-8bc1-4c88-8c85-645847acf16914
797730povidone-iodine 10 % Medicated PadSY35ffe071-8bc1-4c88-8c85-645847acf16914
797730povidone-iodine 10 % Medicated SwabstickSY35ffe071-8bc1-4c88-8c85-645847acf16914
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN43d07956-90ba-4e96-b265-aec03eced19b13
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN5e42914f-de71-4176-819b-9fa26a8bdce613
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD5e42914f-de71-4176-819b-9fa26a8bdce613
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD43d07956-90ba-4e96-b265-aec03eced19b13
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY5e42914f-de71-4176-819b-9fa26a8bdce613
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY43d07956-90ba-4e96-b265-aec03eced19b13
797544isopropyl alcohol 70 % Medicated PadPSNee0d396c-5caa-4a1a-9865-1a742d9d8d6811
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSNee0d396c-5caa-4a1a-9865-1a742d9d8d6811
1737568lidocaine HCl 1 % in 2 ML InjectionPSNee0d396c-5caa-4a1a-9865-1a742d9d8d6811
797730povidone-iodine 10 % Medicated PadPSNee0d396c-5caa-4a1a-9865-1a742d9d8d6811
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCDee0d396c-5caa-4a1a-9865-1a742d9d8d6811
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCDee0d396c-5caa-4a1a-9865-1a742d9d8d6811
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDee0d396c-5caa-4a1a-9865-1a742d9d8d6811
797730povidone-iodine 100 MG/ML Medicated PadSCDee0d396c-5caa-4a1a-9865-1a742d9d8d6811
797544isopropyl alcohol 70 % Medicated PadSYee0d396c-5caa-4a1a-9865-1a742d9d8d6811
797544isopropyl alcohol 70 % Topical ClothSYee0d396c-5caa-4a1a-9865-1a742d9d8d6811
797544isopropyl alcohol 70 % Topical SwabSYee0d396c-5caa-4a1a-9865-1a742d9d8d6811
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSYee0d396c-5caa-4a1a-9865-1a742d9d8d6811
1737568lidocaine HCl 1 % per 2 ML InjectionSYee0d396c-5caa-4a1a-9865-1a742d9d8d6811
1737568lidocaine HCl 20 MG per 2 ML InjectionSYee0d396c-5caa-4a1a-9865-1a742d9d8d6811
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYee0d396c-5caa-4a1a-9865-1a742d9d8d6811
797730povidone-iodine 10 % Medicated PadSYee0d396c-5caa-4a1a-9865-1a742d9d8d6811
797730povidone-iodine 10 % Medicated SwabstickSYee0d396c-5caa-4a1a-9865-1a742d9d8d6811
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN99c06dde-f218-4d81-91e0-f37a748872d63
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD99c06dde-f218-4d81-91e0-f37a748872d63
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY99c06dde-f218-4d81-91e0-f37a748872d63
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSNada639d4-babb-2ad0-e053-2a95a90afce72
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCDada639d4-babb-2ad0-e053-2a95a90afce72
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSYada639d4-babb-2ad0-e053-2a95a90afce72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-118-01722660118011 mL in 1 VIAL1 mlHistorical
72266-118-257226601182525 VIAL in 1 CARTON (72266-118-25) / 1 mL in 1 VIAL (72266-118-01) 25 vial2023-06-230000-00-00NoNoCurrent