FDA.reportPublic FDA data

Dyural 80 Kit

Product NDC
80425-0349
11-digit product format
804250349
Labeler code
80425
Product ID
80425-0349_2a9c2eb6-a6dd-f647-e063-6294a90a93fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone Acetate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine, Sodium Chloride, Isopropyl Alcohol
Dosage form
KIT
Route
EPIDURAL; INFILTRATION; INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRAVENOUS; SOFT TISSUE; SUBCUTANEOUS; TOPICAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-07-31
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dyural 80 Kit
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui797544, 797730, 1725078, 1725082, 1737566, 1743855, 1807631, 1807637, 1807638

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
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cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
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6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316
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3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
a831e694-3663-4a83-82be-6c309429f750Product name220200608
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
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304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
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ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
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c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4887-17Dyural 80 Kit10 mL in 1 VIAL, PLASTICINJECTION10 mL1 mL in 1mL2
0409-4888-02Dyural 80 Kit10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION10 mL9 mg in 1mL2
70121-1574-1Dyural 80 Kit1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION1 mL80 mg in 1mL2
70121-1574-1Dyural 80 Kit1 in 1 CARTONINJECTION, SUSPENSION80 mg in 1mL2
80425-0349-1Dyural 80 Kit1 in 1 CARTONKIT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0349-1EA - Each80425-03497f11a468-d27f-4004-b968-70aa0ff9643d12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0349DYURAL 80 KIT (METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 5 package rows20250102_01ca2f07-9c84-e418-e063-6294a90ac760.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
797544isopropyl alcohol 70 % Medicated PadPSN01ca2f07-9c84-e418-e063-6294a90ac7602
1737566lidocaine HCl 1 % in 5 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
1743855methylPREDNISolone acetate 80 MG in 1 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
797730povidone-iodine 10 % Medicated PadPSN01ca2f07-9c84-e418-e063-6294a90ac7602
1807637sodium chloride 0.9 % in 10 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
1807638sodium chloride 0.9 % in 20 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
1807631sodium chloride 0.9 % in 50 ML InjectionPSN01ca2f07-9c84-e418-e063-6294a90ac7602
17438551 ML methylprednisolone acetate 80 MG/ML InjectionSCD01ca2f07-9c84-e418-e063-6294a90ac7602
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD01ca2f07-9c84-e418-e063-6294a90ac7602
180763710 ML sodium chloride 9 MG/ML InjectionSCD01ca2f07-9c84-e418-e063-6294a90ac7602
180763820 ML sodium chloride 9 MG/ML InjectionSCD01ca2f07-9c84-e418-e063-6294a90ac7602
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD01ca2f07-9c84-e418-e063-6294a90ac7602
17375665 ML lidocaine hydrochloride 10 MG/ML InjectionSCD01ca2f07-9c84-e418-e063-6294a90ac7602
180763150 ML sodium chloride 9 MG/ML InjectionSCD01ca2f07-9c84-e418-e063-6294a90ac7602
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD01ca2f07-9c84-e418-e063-6294a90ac7602
797730povidone-iodine 100 MG/ML Medicated PadSCD01ca2f07-9c84-e418-e063-6294a90ac7602
180763710 ML NaCl 9 MG/ML InjectionSY01ca2f07-9c84-e418-e063-6294a90ac7602
180763820 ML NaCl 9 MG/ML InjectionSY01ca2f07-9c84-e418-e063-6294a90ac7602
180763150 ML NaCl 9 MG/ML InjectionSY01ca2f07-9c84-e418-e063-6294a90ac7602
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY01ca2f07-9c84-e418-e063-6294a90ac7602
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSY01ca2f07-9c84-e418-e063-6294a90ac7602
797544isopropyl alcohol 70 % Medicated PadSY01ca2f07-9c84-e418-e063-6294a90ac7602
797544isopropyl alcohol 70 % Topical ClothSY01ca2f07-9c84-e418-e063-6294a90ac7602
797544isopropyl alcohol 70 % Topical SwabSY01ca2f07-9c84-e418-e063-6294a90ac7602
1737566lidocaine HCl 1 % per 5 ML InjectionSY01ca2f07-9c84-e418-e063-6294a90ac7602
1737566lidocaine HCl 50 MG per 5 ML InjectionSY01ca2f07-9c84-e418-e063-6294a90ac7602
1743855methylprednisolone acetate 80 MG per 1 ML InjectionSY01ca2f07-9c84-e418-e063-6294a90ac7602
1807637normal saline 10 mL InjectionSY01ca2f07-9c84-e418-e063-6294a90ac7602
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY01ca2f07-9c84-e418-e063-6294a90ac7602
797730povidone-iodine 10 % Medicated PadSY01ca2f07-9c84-e418-e063-6294a90ac7602
797730povidone-iodine 10 % Medicated SwabstickSY01ca2f07-9c84-e418-e063-6294a90ac7602
1807637sodium chloride 0.9 % per 10 ML InjectionSY01ca2f07-9c84-e418-e063-6294a90ac7602
1807638sodium chloride 0.9 % per 20 ML InjectionSY01ca2f07-9c84-e418-e063-6294a90ac7602
1807631sodium chloride 0.9 % per 50 ML InjectionSY01ca2f07-9c84-e418-e063-6294a90ac7602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0409-4887-170040948871710 mL in 1 VIAL, PLASTIC10 mlHistorical
0409-4888-020040948880210 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
70121-1574-1701211574011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
80425-0349-1804250349011 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) 1 kit2023-07-31NoNoHistorical