Buprenorphine hydrochloride

Product NDC
63629-4092
11-digit product format
636294092
Labeler code
63629
Product ID
63629-4092_50924708-d935-4e10-825c-b6d340c81efa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
bryant ranch prepack
Application
ANDA020732
Marketing category
ANDA
Marketing start
2009-10-09
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
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-4092-12020-01-31C16284748780-19d75b9d0-df1b-f424-e053-dadaa90a57ceBuprenorphine hydrochloride 8mg
63629-4092-22020-01-31C16284748780-19d75b9d0-df1b-f424-e053-dadaa90a57ceBuprenorphine hydrochloride 8mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4092-1Buprenorphine hydrochloride10 in 1 BOTTLETABLET101002
63629-4092-2Buprenorphine hydrochloride30 in 1 BOTTLETABLET301002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPRENORPHINE HYDROCHLORIDEACTIVE INGREDIENT56W8MW3EN1BUPRENORPHINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1002
BUPRENORPHINEACTIVE MOIETY40D3SCR4GZBUPRENORPHINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1002
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBUPRENORPHINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1002
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GBUPRENORPHINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1002
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPRENORPHINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1002
MANNITOLINACTIVE INGREDIENT3OWL53L36ABUPRENORPHINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1002
POVIDONE K30INACTIVE INGREDIENTU725QWY32XBUPRENORPHINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1002
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBUPRENORPHINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1002
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUPRENORPHINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4092BUPRENORPHINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1002Legacy NDC, 2 package rows20121001_7830fe02-a2ec-48cf-85ce-3e3f6dadab4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351265buprenorphine HCl 8 MG Sublingual TabletPSN7830fe02-a2ec-48cf-85ce-3e3f6dadab4e1002
351265buprenorphine 8 MG Sublingual TabletSCD7830fe02-a2ec-48cf-85ce-3e3f6dadab4e1002
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSY7830fe02-a2ec-48cf-85ce-3e3f6dadab4e1002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63629-4092-16362940920110 in 1 BOTTLEHistorical
63629-4092-26362940920230 in 1 BOTTLEHistorical