FDA.reportPublic FDA data

Buprenorphine Hydrochloride

Product NDC
21695-515
11-digit product format
216950515
Labeler code
21695
Product ID
21695-515_6795ade9-e06e-4daa-bb45-821901a055f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Rebel Distributors Corp
Application
ANDA074137
Marketing category
ANDA
Marketing start
2010-07-12
Marketing end
0000-00-00
Substance
BUPRENORPHINE HYDROCHLORIDE
Active strength
0 mg/mL
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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-515-102019-09-24C16284748780-1934fe258-48f6-48b1-e053-8cdaa90a720aBuprenorphine Hydrochloride Injection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-515-10Buprenorphine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION101
21695-515-10Buprenorphine Hydrochloride1 mL in 1 CARTRIDGEINJECTION, SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-515-10ML - Milliliter21695-5152c294f22-bb46-4008-bf21-af9c0cd021f412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPRENORPHINE HYDROCHLORIDEACTIVE INGREDIENT56W8MW3EN1BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
BuprenorphineACTIVE MOIETY40D3SCR4GZBUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKBUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RBUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-515BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20101220_6795ade9-e06e-4daa-bb45-821901a055f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1655032buprenorphine HCl 0.3 MG in 1 ML CartridgePSN6795ade9-e06e-4daa-bb45-821901a055f51
16550321 ML buprenorphine 0.3 MG/ML CartridgeSCD6795ade9-e06e-4daa-bb45-821901a055f51
1655032buprenorphine 0.3 MG/ML (as buprenorphine HCl 0.324 MG/ML) per 1 ML CartridgeSY6795ade9-e06e-4daa-bb45-821901a055f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-515-102169505151010 in 1 CARTONHistorical