FDA.reportPublic FDA data

BUPRENORPHINE

Product NDC
71335-0950
11-digit product format
713350950
Labeler code
71335
Product ID
71335-0950_942860b1-ae08-462f-927a-d611ad05dc40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPRENORPHINE
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Bryant Ranch Prepack
Application
ANDA207276
Marketing category
ANDA
Marketing start
2017-10-25
Substance
BUPRENORPHINE HYDROCHLORIDE
Active strength
2 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii56W8MW3EN1
Rxcui351264

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
71335-0950-12024-05-15C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-22024-05-15C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-32024-05-15C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-42024-05-15C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-52024-05-15C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-62024-05-15C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-72024-05-15C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-82024-05-15C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-12024-01-30C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-22024-01-30C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-32024-01-30C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-42024-01-30C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-52024-01-30C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-62024-01-30C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-72024-01-30C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981
71335-0950-82024-01-30C16284748780-11030e365-3881-111a-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, CIII Initial U.S. Approval: 1981

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0950-1BUPRENORPHINE60 in 1 BOTTLETABLET607
71335-0950-2BUPRENORPHINE90 in 1 BOTTLETABLET907
71335-0950-3BUPRENORPHINE30 in 1 BOTTLETABLET307
71335-0950-4BUPRENORPHINE7 in 1 BOTTLETABLET77
71335-0950-5BUPRENORPHINE28 in 1 BOTTLETABLET287
71335-0950-6BUPRENORPHINE1 in 1 BOTTLETABLET17
71335-0950-7BUPRENORPHINE12 in 1 BOTTLETABLET127
71335-0950-8BUPRENORPHINE120 in 1 BOTTLETABLET1207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0950-1EA - Each71335-0950575bbc6c-1bc3-45d5-ac8f-bb725b2768a012021-04-08
71335-0950-2EA - Each71335-09508cd1988c-1010-4e2c-9434-049d91e0f68112021-04-08
71335-0950-3EA - Each71335-09500a780a1c-205a-4211-a34a-a101462f6c2212021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0950BUPRENORPHINE TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 8 package rows20240517_a7da638f-f590-4577-bff9-15a91c6e7917.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351264buprenorphine HCl 2 MG Sublingual TabletPSNa7da638f-f590-4577-bff9-15a91c6e79177
351264buprenorphine 2 MG Sublingual TabletSCDa7da638f-f590-4577-bff9-15a91c6e79177
351264buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual TabletSYa7da638f-f590-4577-bff9-15a91c6e79177

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0950-17133509500160 TABLET in 1 BOTTLE (71335-0950-1) 60 tablet2018-09-130000-00-00NoNoCurrent
71335-0950-27133509500290 TABLET in 1 BOTTLE (71335-0950-2) 90 tablet2018-09-130000-00-00NoNoCurrent
71335-0950-37133509500330 TABLET in 1 BOTTLE (71335-0950-3) 30 tablet2022-09-230000-00-00NoNoCurrent
71335-0950-4713350950047 TABLET in 1 BOTTLE (71335-0950-4) 7 tablet2022-09-230000-00-00NoNoCurrent
71335-0950-57133509500528 TABLET in 1 BOTTLE (71335-0950-5) 28 tablet2022-09-230000-00-00NoNoCurrent
71335-0950-6713350950061 TABLET in 1 BOTTLE (71335-0950-6) 1 tablet2022-09-230000-00-00NoNoCurrent
71335-0950-77133509500712 TABLET in 1 BOTTLE (71335-0950-7) 12 tablet2022-09-230000-00-00NoNoCurrent
71335-0950-871335095008120 TABLET in 1 BOTTLE (71335-0950-8) 120 tablet2022-09-230000-00-00NoNoCurrent