FDA.reportPublic FDA data

XARACOLL

Product NDC
51715-100
11-digit product format
517150100
Labeler code
51715
Product ID
51715-100_23477215-fcfc-4b11-a5c3-b2034c31aefb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine HCl Collagen-matrix
Dosage form
IMPLANT
Route
PARENTERAL
Labeler
INNOCOLL PHARMACEUTICALS
Application
NDA209511
Marketing category
NDA
Marketing start
2020-08-28
Marketing end
0000-00-00
Substance
BUPIVACAINE
Active strength
100 mg/1
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51715-100-042024-01-30C16284748780-11030e365-4752-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use XARACOLL ® safely and effectively. See full prescribing information for XARACOLL. XARACOLL ® (bupivacaine hydrochloride) implant Initial U.S. Approval: 1972
51715-100-102024-01-30C16284748780-11030e365-4752-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use XARACOLL ® safely and effectively. See full prescribing information for XARACOLL. XARACOLL ® (bupivacaine hydrochloride) implant Initial U.S. Approval: 1972

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51715-100-04XARACOLL1 in 1 CARTONIMPLANT14
51715-100-04XARACOLL4 in 1 CARTONIMPLANT44
51715-100-10XARACOLL1 in 1 CARTONIMPLANT14
51715-100-10XARACOLL10 in 1 CARTONIMPLANT104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51715-100XARACOLL (BUPIVACAINE HCL COLLAGEN-MATRIX) IMPLANT [INNOCOLL PHARMACEUTICALS]4Legacy NDC, 4 package rows20200912_46da5733-c892-43a5-b826-1898a753f1c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2395798{3 (bupivacaine hydrochloride 100 MG Drug Implant [Xaracoll]) } Pack [Xaracoll 3 Implant Dose]BPCK46da5733-c892-43a5-b826-1898a753f1c34
2395792{3 (bupivacaine hydrochloride 100 MG Drug Implant) } PackGPCK46da5733-c892-43a5-b826-1898a753f1c34
2395791BUPivacaine HCl 100 MG Drug ImplantPSN46da5733-c892-43a5-b826-1898a753f1c34
2395792BUPivacaine HCl 100 MG Drug Implant, 3 Implant DosePSN46da5733-c892-43a5-b826-1898a753f1c34
2395797Xaracoll 100 MG Drug ImplantPSN46da5733-c892-43a5-b826-1898a753f1c34
2395798xaracoll 3 x 100 MG Implant Dose PackPSN46da5733-c892-43a5-b826-1898a753f1c34
2395797bupivacaine hydrochloride 100 MG Drug Implant [Xaracoll]SBD46da5733-c892-43a5-b826-1898a753f1c34
2395791bupivacaine hydrochloride 100 MG Drug ImplantSCD46da5733-c892-43a5-b826-1898a753f1c34
2395792bupivacaine HCl 100 MG Drug Implant, 3 Implant DoseSY46da5733-c892-43a5-b826-1898a753f1c34
2395792bupivacaine hydrochloride 100 MG Drug Implant, 3 Implant DoseSY46da5733-c892-43a5-b826-1898a753f1c34
2395797Xaracoll 100 MG Drug ImplantSY46da5733-c892-43a5-b826-1898a753f1c34
2395798xaracoll 3 x 100 MG Implant Dose PackSY46da5733-c892-43a5-b826-1898a753f1c34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51715-100-04517150100044 CARTON in 1 CARTON (51715-100-04) > 1 POUCH in 1 CARTON > 3 IMPLANT in 1 POUCH4 carton2020-08-280000-00-00NoNoCurrent
51715-100-105171501001010 CARTON in 1 CARTON (51715-100-10) > 1 POUCH in 1 CARTON > 3 IMPLANT in 1 POUCH10 carton2020-08-280000-00-00NoNoCurrent