BUPRENORPHINE

Product NDC
71335-1154
11-digit product format
713351154
Labeler code
71335
Product ID
71335-1154_fffe0a56-1b25-48dc-81c0-a6eb19dead5f
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1154-0BUPRENORPHINE120 in 1 BOTTLETABLET120111
71335-1154-1BUPRENORPHINE90 in 1 BOTTLETABLET90111
71335-1154-2BUPRENORPHINE60 in 1 BOTTLETABLET60111
71335-1154-3BUPRENORPHINE30 in 1 BOTTLETABLET30111
71335-1154-4BUPRENORPHINE20 in 1 BOTTLETABLET20111
71335-1154-5BUPRENORPHINE7 in 1 BOTTLETABLET7111
71335-1154-6BUPRENORPHINE28 in 1 BOTTLETABLET28111
71335-1154-7BUPRENORPHINE1 in 1 BOTTLETABLET1111
71335-1154-8BUPRENORPHINE12 in 1 BOTTLETABLET12111
71335-1154-9BUPRENORPHINE14 in 1 BOTTLETABLET14111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1154-1EA - Each71335-1154d76f5a39-77d5-4aff-b756-8a19860e960712021-04-08
71335-1154-2EA - Each71335-115409a9683f-1b6d-45ed-a8cf-116f7c4ee3dc12021-04-08
71335-1154-3EA - Each71335-11544cc75ac7-c514-4d84-a835-7f657a23432c12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1154BUPRENORPHINE TABLET [BRYANT RANCH PREPACK]110Current NDC, Legacy NDC, 10 package rows20240809_aa132031-9d12-45b4-81e0-4a5877661379.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351265buprenorphine HCl 8 MG Sublingual TabletPSNaa132031-9d12-45b4-81e0-4a5877661379111
351265buprenorphine 8 MG Sublingual TabletSCDaa132031-9d12-45b4-81e0-4a5877661379111
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSYaa132031-9d12-45b4-81e0-4a5877661379111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1154-071335115400120 TABLET in 1 BOTTLE (71335-1154-0) 120 tablet2024-04-030000-00-00NoNoCurrent
71335-1154-17133511540190 TABLET in 1 BOTTLE (71335-1154-1) 90 tablet2019-03-150000-00-00NoNoCurrent
71335-1154-27133511540260 TABLET in 1 BOTTLE (71335-1154-2) 60 tablet2019-03-150000-00-00NoNoCurrent
71335-1154-37133511540330 TABLET in 1 BOTTLE (71335-1154-3) 30 tablet2019-07-220000-00-00NoNoCurrent
71335-1154-47133511540420 TABLET in 1 BOTTLE (71335-1154-4) 20 tablet2024-04-030000-00-00NoNoCurrent
71335-1154-5713351154057 TABLET in 1 BOTTLE (71335-1154-5) 7 tablet2020-01-160000-00-00NoNoCurrent
71335-1154-67133511540628 TABLET in 1 BOTTLE (71335-1154-6) 28 tablet2021-06-280000-00-00NoNoCurrent
71335-1154-7713351154071 TABLET in 1 BOTTLE (71335-1154-7) 1 tablet2024-04-030000-00-00NoNoCurrent
71335-1154-87133511540812 TABLET in 1 BOTTLE (71335-1154-8) 12 tablet2024-04-030000-00-00NoNoCurrent
71335-1154-97133511540914 TABLET in 1 BOTTLE (71335-1154-9) 14 tablet2024-04-030000-00-00NoNoCurrent