Ketorocaine L Kit

Product NDC
76420-771
Requested package NDC
76420-771-01
11-digit product format
764200771
Labeler code
76420
Product ID
76420-771_47db2936-2458-975c-e063-6294a90aaae3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine, Lidocaine Hydrochloride, Povidine Iodine
Dosage form
KIT
Route
INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL
Labeler
Asclemed USA, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-08-15
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 L Kit
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
797730Internal RxNorm lookup
1665461Internal 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
ee0d396c-5caa-4a1a-9865-1a742d9d8d68Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72266-118-01Ketorocaine L Kit1 mL in 1 VIALINJECTION, SOLUTION1 mL30 mg in 1mL11
76420-771-01Ketorocaine L Kit1 in 1 CARTONKIT111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-771-01EA - Each76420-7718e54b8f3-53d8-4a29-930d-b385c93f47ad12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
76420-771KETOROCAINE L KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.]10Current NDC, Legacy NDC, 2 package rows20241008_ee0d396c-5caa-4a1a-9865-1a742d9d8d68.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 L KitKETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINEAsclemed USA, Inc.ee0d396c-5caa-4a1a-9865-1a742d9d8d682026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 76420-771-01
ndc (product): 76420-771
ndc11 (package): 76420077101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-771-01764200771011 KIT in 1 CARTON (76420-771-01) * 10 AMPULE in 1 CARTON (55150-158-72) / 2 mL in 1 AMPULE * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 1 mL in 1 VIAL (72266-118-01) 1 kit2021-09-230000-00-00NoNoCurrent