FDA.reportPublic FDA data

BUPRENORPHINE

Product NDC
50090-5805
11-digit product format
500905805
Labeler code
50090
Product ID
50090-5805_94b57515-d361-4f99-a7e4-fc5f609426c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPRENORPHINE
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
A-S Medication Solutions
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUPRENORPHINE
Listing expiration
2027-12-31

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
50090-5805-02025-07-16C16284748780-1f386c649-a4aa-0266-e053-dadaa90a7c1aThese 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
50090-5805-02023-01-30C16284748780-1f386c649-a4aa-0266-e053-dadaa90a7c1aThese 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
50090-5805-0BUPRENORPHINE30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5805-0EA - Each50090-580552a5c6f8-e3b1-4208-bdec-622504e23f1b12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5805BUPRENORPHINE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, Legacy NDC, 1 package rows20211021_bfb02ea5-22f2-432e-afc8-f1dbe2ea0614.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351265buprenorphine HCl 8 MG Sublingual TabletPSNbfb02ea5-22f2-432e-afc8-f1dbe2ea06145
351265buprenorphine 8 MG Sublingual TabletSCDbfb02ea5-22f2-432e-afc8-f1dbe2ea06145
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSYbfb02ea5-22f2-432e-afc8-f1dbe2ea06145

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5805-05009058050030 TABLET in 1 BOTTLE (50090-5805-0) 30 tablet2021-10-150000-00-00NoNoCurrent