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

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
Bupivilog Kit
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797730Internal RxNorm lookup
1724880Internal RxNorm lookup
1792144Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
01cb7b47-2c40-707d-e063-6294a90a5d97Available on FDA.report

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
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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
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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
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
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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
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87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
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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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0353-1EA - Each80425-0353df505766-2bac-47c2-8ca5-012318c3916712023-09-05

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

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
Bupivilog KitMARCAINE, KENALOG, POVIDONE IODINEAdvanced Rx of Tennessee, LLC01cb7b47-2c40-707d-e063-6294a90a5d972024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 80425-0353

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