buprenorphine hydrochloride

Product NDC
64725-1924
11-digit product format
647251924
Labeler code
64725
Product ID
64725-1924_c9ed63e2-1504-45d7-a33c-94afe98ca244
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine hydrochloride
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
TYA Pharmaceuticals
Application
ANDA090622
Marketing category
ANDA
Marketing start
2010-09-24
Marketing end
0000-00-00
Substance
BUPRENORPHINE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
E
Listing certified through
2017-12-31
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
64725-1924-3buprenorphine hydrochloride30 in 1 BOTTLETABLET303
64725-1924-4buprenorphine hydrochloride30 in 1 CARTONTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-1924BUPRENORPHINE HYDROCHLORIDE TABLET [TYA PHARMACEUTICALS]3Legacy NDC, 2 package rows20160519_89883285-c6f2-487a-b4bb-86f0fbded056.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351264buprenorphine HCl 2 MG Sublingual TabletPSN89883285-c6f2-487a-b4bb-86f0fbded0563
351264buprenorphine 2 MG Sublingual TabletSCD89883285-c6f2-487a-b4bb-86f0fbded0563
351264buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual TabletSY89883285-c6f2-487a-b4bb-86f0fbded0563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-1924-36472519240330 in 1 BOTTLEHistorical
64725-1924-46472519240430 in 1 CARTONHistorical