76420-772 NDC - KETOROCAINE LM KIT (KETOROLAC TROMETHAMINE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE)

Drug Information

Product NDC: 76420-772

Proprietary Name: Ketorocaine LM Kit

Non Proprietary Name: Ketorolac Tromethamine, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine

Active Ingredient(s):


Administration Route(s): EPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICAL

Dosage Form(s): KIT

Labeler Information

Labeler Name: Asclemed USA, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:8/11/2014

Package Information

No. Package Code Package Description Billing Unit
176420-772-011 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, SINGLE-DOSE (72611-722-01)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC76420-772The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEKetorocaine LM KitThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEKetorolac Tromethamine, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine IodineThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEKITThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEEPIDURAL; INFILTRATION; INTRAMUSCULAR; INTRAVENOUS; TOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/11/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMEAsclemed USA, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 2/1/2023