FDA.reportPublic FDA data

Hyronan

Product NDC
76420-306
Requested package NDC
76420-306-01
11-digit product format
764200306
Labeler code
76420
Product ID
76420-306_23b3c2fc-ba89-3dbe-e063-6294a90abb4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Hyaluronate, Lidocaine, Isopropyl Alcohol
Dosage form
KIT
Route
EPIDURAL; INFILTRATION; INTRA-ARTICULAR; TOPICAL
Labeler
Asclemed USA, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-11-15
NDC exclude flag
No
Listing certified through
2026-12-31
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
Hyronan
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup
1737761Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
be8102bb-1250-4d08-b78b-7073ab704e66Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-306-01Hyronan1 in 1 CARTONKIT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-306-01EA - Each76420-30664d74828-8074-48aa-ae94-6ce5fca700b612021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-306HYRONAN (SODIUM HYALURONATE, LIDOCAINE, ISOPROPYL ALCOHOL) KIT [ASCLEMED USA, INC.]4Current NDC, Legacy NDC, 1 package rows20241008_be8102bb-1250-4d08-b78b-7073ab704e66.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HyronanSODIUM HYALURONATE, LIDOCAINE, ISOPROPYL ALCOHOLAsclemed USA, Inc.be8102bb-1250-4d08-b78b-7073ab704e662024-10-04Warnings, Adverse reactionsExact identifier
ndc (package): 76420-306-01
ndc (product): 76420-306
ndc11 (package): 76420030601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSNbe8102bb-1250-4d08-b78b-7073ab704e664
1737761lidocaine HCl 2 % in 5 ML InjectionPSNbe8102bb-1250-4d08-b78b-7073ab704e664
17377615 ML lidocaine hydrochloride 20 MG/ML InjectionSCDbe8102bb-1250-4d08-b78b-7073ab704e664
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDbe8102bb-1250-4d08-b78b-7073ab704e664
797544isopropyl alcohol 70 % Medicated PadSYbe8102bb-1250-4d08-b78b-7073ab704e664
797544isopropyl alcohol 70 % Topical ClothSYbe8102bb-1250-4d08-b78b-7073ab704e664
797544isopropyl alcohol 70 % Topical SwabSYbe8102bb-1250-4d08-b78b-7073ab704e664
1737761lidocaine HCl 100 MG per 5 ML InjectionSYbe8102bb-1250-4d08-b78b-7073ab704e664
1737761lidocaine HCl 2 % per 5 ML InjectionSYbe8102bb-1250-4d08-b78b-7073ab704e664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-306-01764200306011 KIT in 1 CARTON (76420-306-01) * 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-165-05) / 5 mL in 1 VIAL, SINGLE-DOSE * 5 mL in 1 POUCH1 kit2020-11-150000-00-00NoNoCurrent