FDA.reportPublic FDA data

Ketorocaine LM Kit

Product NDC
76420-772
11-digit product format
764200772
Labeler code
76420
Product ID
76420-772_47db17be-5162-7575-e063-6294a90a923a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine
Dosage form
KIT
Route
EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL
Labeler
Asclemed USA, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-08-11
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Ketorocaine LM Kit
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
797730Internal RxNorm lookup
1665461Internal RxNorm lookup
1725078Internal RxNorm lookup
1725082Internal RxNorm lookup
1737568Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
35ffe071-8bc1-4c88-8c85-645847acf169Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72266-118-01Ketorocaine LM Kit1 mL in 1 VIALINJECTION, SOLUTION1 mL30 mg in 1mL14
76420-772-01Ketorocaine LM Kit1 in 1 CARTONKIT114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-772-01EA - Each76420-77219b821c0-86b5-4d27-a0aa-fc3a72a7b45f12015-07-20

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-772KETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]13Current NDC, Legacy NDC, 2 package rows20241008_35ffe071-8bc1-4c88-8c85-645847acf169.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorocaine LM KitKETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.35ffe071-8bc1-4c88-8c85-645847acf1692026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 76420-772

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSNfb81d452-30e0-f019-e053-6394a90a76342
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSNfb81d452-30e0-f019-e053-6394a90a76342
797544isopropyl alcohol 70 % Medicated PadPSNfb81d452-30e0-f019-e053-6394a90a76342
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSNfb81d452-30e0-f019-e053-6394a90a76342
1737568lidocaine HCl 1 % in 2 ML InjectionPSNfb81d452-30e0-f019-e053-6394a90a76342
797730povidone-iodine 10 % Medicated PadPSNfb81d452-30e0-f019-e053-6394a90a76342
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCDfb81d452-30e0-f019-e053-6394a90a76342
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDfb81d452-30e0-f019-e053-6394a90a76342
17375682 ML lidocaine hydrochloride 10 MG/ML InjectionSCDfb81d452-30e0-f019-e053-6394a90a76342
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDfb81d452-30e0-f019-e053-6394a90a76342
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDfb81d452-30e0-f019-e053-6394a90a76342
797730povidone-iodine 100 MG/ML Medicated PadSCDfb81d452-30e0-f019-e053-6394a90a76342
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSYfb81d452-30e0-f019-e053-6394a90a76342
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSYfb81d452-30e0-f019-e053-6394a90a76342
797544isopropyl alcohol 70 % Medicated PadSYfb81d452-30e0-f019-e053-6394a90a76342
797544isopropyl alcohol 70 % Topical ClothSYfb81d452-30e0-f019-e053-6394a90a76342
797544isopropyl alcohol 70 % Topical SwabSYfb81d452-30e0-f019-e053-6394a90a76342
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSYfb81d452-30e0-f019-e053-6394a90a76342
1737568lidocaine HCl 1 % per 2 ML InjectionSYfb81d452-30e0-f019-e053-6394a90a76342
1737568lidocaine HCl 20 MG per 2 ML InjectionSYfb81d452-30e0-f019-e053-6394a90a76342
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSYfb81d452-30e0-f019-e053-6394a90a76342
797730povidone-iodine 10 % Medicated PadSYfb81d452-30e0-f019-e053-6394a90a76342
797730povidone-iodine 10 % Medicated SwabstickSYfb81d452-30e0-f019-e053-6394a90a76342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-118-01722660118011 mL in 1 VIAL1 mlHistorical
76420-772-01764200772011 KIT in 1 CARTON (76420-772-01) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 10 AMPULE in 1 CARTON (55150-158-72) / 2 mL in 1 AMPULE * 1 mL in 1 VIAL (72266-118-01) 1 kit2021-09-230000-00-00NoNoCurrent