dyural lm kit

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 lm kit
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 SOFT TISSUE TOPICAL
Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-795
Product ID 76420-795_47db32a5-369f-59f4-e063-6394a90ab582
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2027-12-31
Marketing Start 2014-08-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420795
Hyphenated Format 76420-795

Supplemental Identifiers

RxCUI
797544 797730 1725078 1725082 1737566 1743779

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 lm kit (source: ndc)
Generic Name methylprednisolone acetate, lidocaine hydrochloride, bupivacaine hydrochloride, povidine iodine, isopropyl alcohol (source: ndc)
Routes
EPIDURAL INFILTRATION INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR SOFT TISSUE 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
  • 40 mg/ml
  • 1 ml
  • 1 %
  • 10 mg/ml
  • 5 ml
  • 10 %
  • 9.85 %
  • 70 %
source: label
Packaging
  • 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
source: ndc

Packages (1)

76420-795-01 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

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Dyural LM Kit ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INFILTRATION", "INTRA-ARTICULAR", "INTRALESIONAL", "INTRAMUSCULAR", "SOFT TISSUE", "TOPICAL"], "spl_id": "47db32a5-369f-59f4-e063-6394a90ab582", "openfda": {"rxcui": ["797544", "797730", "1725078", "1725082", "1737566", "1743779"], "spl_set_id": ["cdd72141-10b6-48c6-85be-5b1294c8539c"], "manufacturer_name": ["Asclemed USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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", "package_ndc": "76420-795-01", "marketing_start_date": "20140821"}], "brand_name": "Dyural LM Kit", "product_id": "76420-795_47db32a5-369f-59f4-e063-6394a90ab582", "dosage_form": "KIT", "product_ndc": "76420-795", "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 LM Kit", "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20140821", "listing_expiration_date": "20271231"}