Home NDC 80425-0245 Ketorocaine LM Kit
Product NDC 80425-0245
11-digit product format 804250245
Labeler code 80425
Product ID 80425-0245_2a9ad9e4-1651-c0dc-e063-6294a90a6e45
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketorolac Tromethamine, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine
Dosage form KIT
Route EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL
Labeler Advanced Rx Pharmacy of Tennessee, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2023-05-12
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 797544 Internal RxNorm lookup 797730 Internal RxNorm lookup 1665461 Internal RxNorm lookup 1725078 Internal RxNorm lookup 1725082 Internal RxNorm lookup 1737568 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72611-722-01 Ketorocaine LM Kit 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 mL 30 mg in 1mL 2 80425-0245-1 Ketorocaine LM Kit 1 in 1 CARTON KIT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0245 KETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC] 2 Current NDC, 2 package rows 20250102_fb81d452-30e0-f019-e053-6394a90a7634.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ketorocaine LM Kit KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE Advanced Rx Pharmacy of Tennessee, LLC fb81d452-30e0-f019-e053-6394a90a7634 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (product): 80425-0245
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72611-722-01 72611072201 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 80425-0245-1 80425024501 1 KIT in 1 CARTON (80425-0245-1) * 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, SINGLE-DOSE (72611-722-01) 1 kit 2023-05-12 No No Current