Home NDC 76420-795 Dyural LM Kit
Product NDC 76420-795
11-digit product format 764200795
Labeler code 76420
Product ID 76420-795_47db32a5-369f-59f4-e063-6394a90ab582
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol
Dosage form KIT
Route EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE; TOPICAL
Labeler Asclemed USA, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2014-08-21
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 Dyural LM Kit
Listing expiration 2027-12-31 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 1725078 Internal RxNorm lookup 1725082 Internal RxNorm lookup 1737566 Internal RxNorm lookup 1743779 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 70121-1573-5 Dyural LM Kit 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SUSPENSION 1 mL 40 mg in 1mL 12 70121-1573-5 Dyural LM Kit 25 in 1 CARTON INJECTION, SUSPENSION 40 mg in 1mL 12 76420-795-01 Dyural LM Kit 1 in 1 CARTON KIT 1 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Bupivacaine Hydrochloride ACTIVE INGREDIENT 7TQO7W3VT8 DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Isopropyl Alcohol ACTIVE INGREDIENT ND2M416302 DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Lidocaine Hydrochloride ACTIVE INGREDIENT V13007Z41A DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Methylprednisolone Acetate ACTIVE INGREDIENT 43502P7F0P DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Povidone-Iodine ACTIVE INGREDIENT 85H0HZU99M DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Bupivacaine ACTIVE MOIETY Y8335394RO DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Iodine ACTIVE MOIETY 9679TC07X4 DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Isopropyl Alcohol ACTIVE MOIETY ND2M416302 DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Lidocaine ACTIVE MOIETY 98PI200987 DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Methylprednisolone ACTIVE MOIETY X4W7ZR7023 DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Nonoxynol-9 INACTIVE INGREDIENT 48Q180SH9T DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Polyethylene Glycol 3350 INACTIVE INGREDIENT G2M7P15E5P DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-795 DYURAL LM KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.] 11 Current NDC, Legacy NDC, 3 package rows 20241008_cdd72141-10b6-48c6-85be-5b1294c8539c.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 Dyural LM Kit METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL Asclemed USA, Inc. cdd72141-10b6-48c6-85be-5b1294c8539c 2026-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (product): 76420-795
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70121-1573-5 70121157305 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 76420-795-01 76420079501 1 KIT in 1 CARTON (76420-795-01) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05) / 5 mL in 1 VIAL, SINGLE-DOSE * 25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1573-5) / 1 mL in 1 VIAL, SINGLE-DOSE 1 kit 2014-08-21 0000-00-00 No No Current