FDA.reportPublic FDA data

Buprenorphine

Product NDC
50268-129
11-digit product format
502680129
Labeler code
50268
Product ID
50268-129_47e239f0-069e-a3e1-e063-6294a90a7bf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
AvPAK
Application
ANDA201760
Marketing category
ANDA
Marketing start
2024-03-19
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
Rxcui351264, 351265

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68654759-f50b-79ef-24c5-544d94fe7d87Product name320251114
08a295bb-88df-4ab0-a120-a75a789a74f1Product name120231013
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
a5920611-4285-f024-69b9-39ff338b81eaProduct name520170609
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-129-11Buprenorphine1 in 1 BLISTER PACKTABLET12
50268-129-15Buprenorphine50 in 1 BOXTABLET502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-129-11EA - Each50268-129d41f65b3-2820-48e5-a439-a791cb216bfc12024-04-05
50268-129-15EA - Each50268-129e3730804-53e1-4fd6-b7e0-3e04e57e2f1d12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-129BUPRENORPHINE TABLET [AVPAK]1Current NDC, 2 package rows20240321_1408cd8f-a0b5-6be7-e063-6394a90a0b41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351264buprenorphine HCl 2 MG Sublingual TabletPSN1408cd8f-a0b5-6be7-e063-6394a90a0b412
351265buprenorphine HCl 8 MG Sublingual TabletPSN1408cd8f-a0b5-6be7-e063-6394a90a0b412
351264buprenorphine 2 MG Sublingual TabletSCD1408cd8f-a0b5-6be7-e063-6394a90a0b412
351265buprenorphine 8 MG Sublingual TabletSCD1408cd8f-a0b5-6be7-e063-6394a90a0b412
351264buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual TabletSY1408cd8f-a0b5-6be7-e063-6394a90a0b412
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSY1408cd8f-a0b5-6be7-e063-6394a90a0b412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-129-11502680129111 in 1 BLISTER PACKHistorical
50268-129-155026801291550 BLISTER PACK in 1 BOX (50268-129-15) / 1 TABLET in 1 BLISTER PACK (50268-129-11) 50 blister pack2024-03-19NoNoHistorical