FDA.reportPublic FDA data

Buprenorphine and Naloxone

Product NDC
71335-1378
11-digit product format
713351378
Labeler code
71335
Product ID
71335-1378_154fc76d-ff38-473b-aaa5-017237455b85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine and Naloxone
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Bryant Ranch Prepack
Application
ANDA205022
Marketing category
ANDA
Marketing start
2016-09-19
Substance
BUPRENORPHINE; NALOXONE
Active strength
8; 2 mg/1; mg/1
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA], 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 and Naloxone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE8 mg/1
NALOXONE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii40D3SCR4GZ, 36B82AMQ7N
Rxcui351267

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68654759-f50b-79ef-24c5-544d94fe7d87Product name320251114
c955d208-c333-9bd7-be34-d7e12986d44eProduct name620250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304Product name120250204
caa6391e-3db3-c912-335f-61b5fc00aa12Product name920240110
08a295bb-88df-4ab0-a120-a75a789a74f1Product name120231013
65a3bc34-04ff-4cf1-aad9-c7d92a062f6dProduct name120231003
e951cdf3-f269-4d97-a7d5-c1c3d7283a7dProduct name320230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
f327b80c-8fa2-404b-838a-df3eec141cf2Product name120221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119Product name120220511
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9Product name120211026
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
a5920611-4285-f024-69b9-39ff338b81eaProduct name520170609
0b8c7273-1da3-495f-909a-7cf1e96d2361Product name120161212
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1378-02024-05-20C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-12024-05-20C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-22024-05-20C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-32024-05-20C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-42024-05-20C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-52024-05-20C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-62024-05-20C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-72024-05-20C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-82024-05-20C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-92024-05-20C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-02024-01-30C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-12024-01-30C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-22024-01-30C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-32024-01-30C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-42024-01-30C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-52024-01-30C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-62024-01-30C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-72024-01-30C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-82024-01-30C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
71335-1378-92024-01-30C16284748780-11030e365-08fc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE and NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1378-0Buprenorphine and Naloxone42 in 1 BOTTLETABLET42103
71335-1378-1Buprenorphine and Naloxone30 in 1 BOTTLETABLET30103
71335-1378-2Buprenorphine and Naloxone60 in 1 BOTTLETABLET60103
71335-1378-3Buprenorphine and Naloxone90 in 1 BOTTLETABLET90103
71335-1378-4Buprenorphine and Naloxone120 in 1 BOTTLETABLET120103
71335-1378-5Buprenorphine and Naloxone14 in 1 BOTTLETABLET14103
71335-1378-6Buprenorphine and Naloxone28 in 1 BOTTLETABLET28103
71335-1378-7Buprenorphine and Naloxone6 in 1 BOTTLETABLET6103
71335-1378-8Buprenorphine and Naloxone10 in 1 BOTTLETABLET10103
71335-1378-9Buprenorphine and Naloxone21 in 1 BOTTLETABLET21103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1378-1EA - Each71335-13786c00a080-c80a-4959-aabc-fca05898239712022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1378BUPRENORPHINE AND NALOXONE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240522_2063d5bf-b3bc-4e73-9046-7e994446ab50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351267buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual TabletPSN2063d5bf-b3bc-4e73-9046-7e994446ab50103
351267buprenorphine 8 MG / naloxone 2 MG Sublingual TabletSCD2063d5bf-b3bc-4e73-9046-7e994446ab50103
351267buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual TabletSY2063d5bf-b3bc-4e73-9046-7e994446ab50103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1378-07133513780042 TABLET in 1 BOTTLE (71335-1378-0) 42 tablet2024-05-200000-00-00NoNoCurrent
71335-1378-17133513780130 TABLET in 1 BOTTLE (71335-1378-1) 30 tablet2019-10-250000-00-00NoNoCurrent
71335-1378-27133513780260 TABLET in 1 BOTTLE (71335-1378-2) 60 tablet2024-05-200000-00-00NoNoCurrent
71335-1378-37133513780390 TABLET in 1 BOTTLE (71335-1378-3) 90 tablet2024-05-200000-00-00NoNoCurrent
71335-1378-471335137804120 TABLET in 1 BOTTLE (71335-1378-4) 120 tablet2024-05-200000-00-00NoNoCurrent
71335-1378-57133513780514 TABLET in 1 BOTTLE (71335-1378-5) 14 tablet2024-05-200000-00-00NoNoCurrent
71335-1378-67133513780628 TABLET in 1 BOTTLE (71335-1378-6) 28 tablet2024-05-200000-00-00NoNoCurrent
71335-1378-7713351378076 TABLET in 1 BOTTLE (71335-1378-7) 6 tablet2024-05-200000-00-00NoNoCurrent
71335-1378-87133513780810 TABLET in 1 BOTTLE (71335-1378-8) 10 tablet2024-05-200000-00-00NoNoCurrent
71335-1378-97133513780921 TABLET in 1 BOTTLE (71335-1378-9) 21 tablet2024-05-200000-00-00NoNoCurrent