BUPRENORPHINE

Product NDC
72162-1344
11-digit product format
721621344
Labeler code
72162
Product ID
72162-1344_c2aee9fc-34eb-4689-a0bc-35749dd20d48
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1344-3BUPRENORPHINE30 in 1 BOTTLETABLET30104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1344-3EA - Each72162-1344c0b62ae7-f6bd-4a2f-a049-38763d4d4ef912024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1344BUPRENORPHINE TABLET [BRYANT RANCH PREPACK]103Current NDC, 1 package rows20240809_cd0a90c6-32cc-4114-8573-86ac85503bdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351264buprenorphine HCl 2 MG Sublingual TabletPSNcd0a90c6-32cc-4114-8573-86ac85503bdf104
351264buprenorphine 2 MG Sublingual TabletSCDcd0a90c6-32cc-4114-8573-86ac85503bdf104
351264buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual TabletSYcd0a90c6-32cc-4114-8573-86ac85503bdf104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1344-37216213440330 TABLET in 1 BOTTLE (72162-1344-3) 30 tablet2026-04-03NoNoHistorical