FDA.reportPublic FDA data

Bupivilog Kit

Product NDC
80425-0353
11-digit product format
804250353
Labeler code
80425
Product ID
80425-0353_2a9c0c91-2b39-4def-e063-6294a90a58ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
marcaine, kenalog, povidone iodine
Dosage form
KIT
Route
EPIDURAL; INTRA-ARTICULAR; INTRAMUSCULAR; TOPICAL
Labeler
Advanced Rx 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
Bupivilog Kit
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui797730, 1724880, 1792144

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
a831e694-3663-4a83-82be-6c309429f750Product name220200608
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1049-5Bupivilog Kit1 mL in 1 VIALINJECTION, SUSPENSION2 mL40 mg in 1mL2
70121-1049-5Bupivilog Kit25 in 1 CARTONINJECTION, SUSPENSION40 mg in 1mL2
80425-0353-1Bupivilog Kit1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0353BUPIVILOG KIT (MARCAINE, KENALOG, POVIDONE IODINE) KIT [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_01cb7b47-2c40-707d-e063-6294a90a5d97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSN01cb7b47-2c40-707d-e063-6294a90a5d972
797730povidone-iodine 10 % Medicated PadPSN01cb7b47-2c40-707d-e063-6294a90a5d972
1792144triamcinolone acetonide 40 MG in 1 ML InjectionPSN01cb7b47-2c40-707d-e063-6294a90a5d972
17921441 ML triamcinolone acetonide 40 MG/ML InjectionSCD01cb7b47-2c40-707d-e063-6294a90a5d972
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD01cb7b47-2c40-707d-e063-6294a90a5d972
797730povidone-iodine 100 MG/ML Medicated PadSCD01cb7b47-2c40-707d-e063-6294a90a5d972
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSY01cb7b47-2c40-707d-e063-6294a90a5d972
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY01cb7b47-2c40-707d-e063-6294a90a5d972
797730povidone-iodine 10 % Medicated PadSY01cb7b47-2c40-707d-e063-6294a90a5d972
797730povidone-iodine 10 % Medicated SwabstickSY01cb7b47-2c40-707d-e063-6294a90a5d972
1792144triamcinolone acetonide 40 MG per 1 ML InjectionSY01cb7b47-2c40-707d-e063-6294a90a5d972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70121-1049-5701211049051 mL in 1 VIAL1 mlHistorical
80425-0353-1804250353011 KIT in 1 CARTON (80425-0353-1) * 25 VIAL in 1 CARTON (70121-1049-5) / 1 mL in 1 VIAL * .9 mL in 1 PACKET (67777-419-02) * 10 mL in 1 VIAL, SINGLE-DOSE (0409-1162-18) 1 kit2023-07-31NoNoCurrent