NDC 76420-796

Dyural 80-LM

Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol

Dyural 80-LM is a Epidural; Infiltration; Intra-articular; Intralesional; Intramuscular; Intravenous; Soft Tissue; Subcutaneous; Topical Kit in the Human Prescription Drug category. It is labeled and distributed by Asclemed Usa, Inc.. The primary component is .

Product ID76420-796_d55b83fd-179c-67d4-e053-2a95a90ac8a6
NDC76420-796
Product TypeHuman Prescription Drug
Proprietary NameDyural 80-LM
Generic NameMethylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol
Dosage FormKit
Route of AdministrationEPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE; SUBCUTANEOUS; TOPICAL
Marketing Start Date2022-01-11
Marketing CategoryUNAPPROVED DRUG OTHER /
Labeler NameAsclemed USA, Inc.
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 76420-796-01

1 KIT in 1 CARTON (76420-796-01) * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05) > 5 mL in 1 VIAL, SINGLE-DOSE * 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-167-10) > 10 mL in 1 VIAL, SINGLE-DOSE * .9 mL in 1 PACKET (67777-419-02) * 1 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-3475-01) > 1 mL in 1 VIAL, SINGLE-DOSE * 5 mL in 1 POUCH
Marketing Start Date2022-01-11
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Dyural 80-LM" or generic name "Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol"

NDCBrand NameGeneric Name
76420-796Dyural 80-LMMethylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol
76420-795Dyural LM KitMethylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.