FDA.reportPublic FDA data

Buprenorphine HCl

Product NDC
71335-1163
11-digit product format
713351163
Labeler code
71335
Product ID
71335-1163_4ee49cc8-55ca-4274-9ea6-70d7891d8853
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine HCl
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Bryant Ranch Prepack
Application
ANDA078633
Marketing category
ANDA
Marketing start
2009-10-08
Substance
BUPRENORPHINE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Buprenorphine HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii56W8MW3EN1
Rxcui351265

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1163-02024-05-20C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-12024-05-20C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-22024-05-20C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-32024-05-20C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-42024-05-20C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-52024-05-20C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-62024-05-20C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-72024-05-20C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-82024-05-20C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-92024-05-20C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-02024-01-30C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-12024-01-30C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-22024-01-30C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-32024-01-30C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-42024-01-30C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-52024-01-30C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-62024-01-30C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-72024-01-30C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-82024-01-30C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981
71335-1163-92024-01-30C16284748780-11030e365-67aa-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE SUBLINGUAL TABLETS. BUPRENORPHINE sublingual tablets, for sublingual administration CIII Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1163-0Buprenorphine HCl120 in 1 BOTTLETABLET1207
71335-1163-1Buprenorphine HCl90 in 1 BOTTLETABLET907
71335-1163-2Buprenorphine HCl60 in 1 BOTTLETABLET607
71335-1163-3Buprenorphine HCl30 in 1 BOTTLETABLET307
71335-1163-4Buprenorphine HCl20 in 1 BOTTLETABLET207
71335-1163-5Buprenorphine HCl7 in 1 BOTTLETABLET77
71335-1163-6Buprenorphine HCl28 in 1 BOTTLETABLET287
71335-1163-7Buprenorphine HCl1 in 1 BOTTLETABLET17
71335-1163-8Buprenorphine HCl12 in 1 BOTTLETABLET127
71335-1163-9Buprenorphine HCl14 in 1 BOTTLETABLET147

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1163-1EA - Each71335-11638541cd7b-30c3-4502-bb02-5b7544b8fe0812021-04-08
71335-1163-2EA - Each71335-1163d2607102-2a9c-4034-b169-098b624c55f312021-04-08
71335-1163-3EA - Each71335-1163e89c974d-a9f4-44e6-aa80-92df7d6c6a9512021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1163BUPRENORPHINE HCL TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 10 package rows20250331_d5a8c41e-413e-4d48-9739-d158e5681dd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351265buprenorphine HCl 8 MG Sublingual TabletPSNd5a8c41e-413e-4d48-9739-d158e5681dd07
351265buprenorphine 8 MG Sublingual TabletSCDd5a8c41e-413e-4d48-9739-d158e5681dd07
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSYd5a8c41e-413e-4d48-9739-d158e5681dd07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1163-071335116300120 TABLET in 1 BOTTLE (71335-1163-0) 120 tablet2024-05-170000-00-00NoNoCurrent
71335-1163-17133511630190 TABLET in 1 BOTTLE (71335-1163-1) 90 tablet2019-03-210000-00-00NoNoCurrent
71335-1163-27133511630260 TABLET in 1 BOTTLE (71335-1163-2) 60 tablet2019-04-240000-00-00NoNoCurrent
71335-1163-37133511630330 TABLET in 1 BOTTLE (71335-1163-3) 30 tablet2019-04-010000-00-00NoNoCurrent
71335-1163-47133511630420 TABLET in 1 BOTTLE (71335-1163-4) 20 tablet2024-05-170000-00-00NoNoCurrent
71335-1163-5713351163057 TABLET in 1 BOTTLE (71335-1163-5) 7 tablet2024-05-170000-00-00NoNoCurrent
71335-1163-67133511630628 TABLET in 1 BOTTLE (71335-1163-6) 28 tablet2024-05-170000-00-00NoNoCurrent
71335-1163-7713351163071 TABLET in 1 BOTTLE (71335-1163-7) 1 tablet2024-05-170000-00-00NoNoCurrent
71335-1163-87133511630812 TABLET in 1 BOTTLE (71335-1163-8) 12 tablet2024-05-170000-00-00NoNoCurrent
71335-1163-97133511630914 TABLET in 1 BOTTLE (71335-1163-9) 14 tablet2024-05-170000-00-00NoNoCurrent