dyural 80-lm

Generic: methylprednisolone acetate, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine, isopropyl alcohol

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name dyural 80-lm
Generic Name methylprednisolone acetate, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine, isopropyl alcohol
Labeler asclemed usa, inc.
Dosage Form KIT
Routes
EPIDURAL INFILTRATION INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR INTRAVENOUS SOFT TISSUE SUBCUTANEOUS TOPICAL
Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-796
Product ID 76420-796_23b53a4c-c516-cabc-e063-6394a90ab44e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2022-01-11

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420796
Hyphenated Format 76420-796

Supplemental Identifiers

RxCUI
797544 797730 1725078 1725082 1737566 1743855

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dyural 80-lm (source: ndc)
Generic Name methylprednisolone acetate, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine, isopropyl alcohol (source: ndc)
Routes
EPIDURAL INFILTRATION INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR INTRAVENOUS SOFT TISSUE SUBCUTANEOUS TOPICAL
source: ndc

Resolved Composition

Strengths
  • 0.25 %
  • 25 mg/10 ml
  • 2.5 mg/ml
  • 75 mg/30 ml
  • 125 mg/50 ml
  • 0.5 %
  • 50 mg/10 ml
  • 5 mg/ml
  • 150 mg/30 ml
  • 250 mg/50 ml
  • 0.75 %
  • 75 mg/10 ml
  • 7.5 mg/ml
  • 225 mg/30 ml
  • 80 mg/ml
  • 1 ml
  • 1 %
  • 10 mg/ml
  • 5 ml
  • 10 %
  • 9.85 %
  • 70 %
source: label
Packaging
  • 1 KIT in 1 CARTON (76420-796-01) * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1574-1) / 1 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

76420-796-01 1 KIT in 1 CARTON (76420-796-01) * .9 mL in 1 PACKET (67777-419-02) * 5 mL in 1 POUCH * 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1574-1) / 1 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18) * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Dyural 80-LM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INFILTRATION", "INTRA-ARTICULAR", "INTRALESIONAL", "INTRAMUSCULAR", "INTRAVENOUS", "SOFT TISSUE", "SUBCUTANEOUS", "TOPICAL"], "spl_id": "23b53a4c-c516-cabc-e063-6394a90ab44e", "openfda": {"rxcui": ["797544", "797730", "1725078", "1725082", "1737566", "1743855"], "spl_set_id": ["c4071146-7d89-4c3a-9278-389d801cf66d"], "manufacturer_name": ["Asclemed USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (76420-796-01)  *  .9 mL in 1 PACKET (67777-419-02)  *  5 mL in 1 POUCH *  1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1574-1)  / 1 mL in 1 VIAL, SINGLE-DOSE *  10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18)  *  10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "76420-796-01", "marketing_start_date": "20220111"}], "brand_name": "Dyural 80-LM", "product_id": "76420-796_23b53a4c-c516-cabc-e063-6394a90ab44e", "dosage_form": "KIT", "product_ndc": "76420-796", "generic_name": "Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Isopropyl Alcohol", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dyural 80-LM", "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20220111", "listing_expiration_date": "20261231"}