dyural 80 kit

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

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name dyural 80 kit
Generic Name methylprednisolone acetate, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine, sodium chloride, isopropyl alcohol
Labeler advanced rx pharmacy of tennessee, llc
Dosage Form KIT
Routes
EPIDURAL INFILTRATION INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR INTRAVENOUS SOFT TISSUE SUBCUTANEOUS TOPICAL
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0349
Product ID 80425-0349_2a9c2eb6-a6dd-f647-e063-6294a90a93fe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2023-07-31

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250349
Hyphenated Format 80425-0349

Supplemental Identifiers

RxCUI
797544 797730 1725078 1725082 1737566 1743855 1807631 1807637 1807638

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 kit (source: ndc)
Generic Name methylprednisolone acetate, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine, sodium chloride, 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
  • 0.9 %
  • 10 ml
  • 10 %
  • 9.85 %
  • 70 %
source: label
Packaging
  • 1 KIT in 1 CARTON (80425-0349-1) * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) * 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1574-1) / 1 mL in 1 VIAL, SINGLE-DOSE * 5 mL in 1 POUCH * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05) / 5 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL, SINGLE-DOSE (0409-4888-02) * .9 mL in 1 PACKET (67777-419-02) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18)
source: ndc

Packages (1)

80425-0349-1 1 KIT in 1 CARTON (80425-0349-1) * 10 mL in 1 VIAL, PLASTIC (0409-4887-17) * 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1574-1) / 1 mL in 1 VIAL, SINGLE-DOSE * 5 mL in 1 POUCH * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05) / 5 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL, SINGLE-DOSE (0409-4888-02) * .9 mL in 1 PACKET (67777-419-02) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Dyural 80 Kit 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": "2a9c2eb6-a6dd-f647-e063-6294a90a93fe", "openfda": {"rxcui": ["797544", "797730", "1725078", "1725082", "1737566", "1743855", "1807631", "1807637", "1807638"], "spl_set_id": ["01ca2f07-9c84-e418-e063-6294a90ac760"], "manufacturer_name": ["Advanced Rx Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (80425-0349-1)  *  10 mL in 1 VIAL, PLASTIC (0409-4887-17)  *  1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1574-1)  / 1 mL in 1 VIAL, SINGLE-DOSE *  5 mL in 1 POUCH *  10 VIAL, SINGLE-DOSE in 1 CARTON (55150-162-05)  / 5 mL in 1 VIAL, SINGLE-DOSE *  10 mL in 1 VIAL, SINGLE-DOSE (0409-4888-02)  *  .9 mL in 1 PACKET (67777-419-02)  *  10 mL in 1 VIAL, SINGLE-DOSE (0409-1159-18)", "package_ndc": "80425-0349-1", "marketing_start_date": "20230731"}], "brand_name": "Dyural 80 Kit", "product_id": "80425-0349_2a9c2eb6-a6dd-f647-e063-6294a90a93fe", "dosage_form": "KIT", "product_ndc": "80425-0349", "generic_name": "Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Sodium Chloride, Isopropyl Alcohol", "labeler_name": "Advanced Rx Pharmacy of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dyural 80 Kit", "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20230731", "listing_expiration_date": "20261231"}