BUPRENORPHINE

Product NDC
68071-2592
11-digit product format
680712592
Labeler code
68071
Product ID
68071-2592_d2940ffb-c13c-c66b-e053-2995a90aaba0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPRENORPHINE
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA207276
Marketing category
ANDA
Marketing start
2017-10-25
Marketing end
0000-00-00
Substance
BUPRENORPHINE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68654759-f50b-79ef-24c5-544d94fe7d87Product name320251114
08a295bb-88df-4ab0-a120-a75a789a74f1Product name120231013
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
a5920611-4285-f024-69b9-39ff338b81eaProduct name520170609
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2592-3BUPRENORPHINE30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2592BUPRENORPHINE TABLET [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20230718_d2940ffb-c13b-c66b-e053-2995a90aaba0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351265buprenorphine HCl 8 MG Sublingual TabletPSNd2940ffb-c13b-c66b-e053-2995a90aaba02
351265buprenorphine 8 MG Sublingual TabletSCDd2940ffb-c13b-c66b-e053-2995a90aaba02
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSYd2940ffb-c13b-c66b-e053-2995a90aaba02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2592-36807125920330 TABLET in 1 BOTTLE (68071-2592-3) 30 tablet2021-12-070000-00-00NoNoCurrent