FDA.reportPublic FDA data

buprenorphine hydrochloride

Product NDC
72888-182
11-digit product format
728880182
Labeler code
72888
Product ID
72888-182_47a1af00-e74e-d1cc-e063-6394a90ab889
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine hydrochloride
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Advagen Pharma Ltd
Application
ANDA090279
Marketing category
ANDA
Marketing start
2015-06-10
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 hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 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
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
72888-182-30buprenorphine hydrochloride30 in 1 BOTTLETABLET306
72888-182-90buprenorphine hydrochloride90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-182-30EA - Each72888-1826bb05631-4dab-4ce3-86d3-b25b14cc2bfa12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-182BUPRENORPHINE HYDROCHLORIDE TABLET [ADVAGEN PHARMA LTD]3Current NDC, 2 package rows20240608_699638dd-3a53-445f-a545-d0e6eabfe1c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351264buprenorphine HCl 2 MG Sublingual TabletPSN699638dd-3a53-445f-a545-d0e6eabfe1c96
351265buprenorphine HCl 8 MG Sublingual TabletPSN699638dd-3a53-445f-a545-d0e6eabfe1c96
351264buprenorphine 2 MG Sublingual TabletSCD699638dd-3a53-445f-a545-d0e6eabfe1c96
351265buprenorphine 8 MG Sublingual TabletSCD699638dd-3a53-445f-a545-d0e6eabfe1c96
351264buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual TabletSY699638dd-3a53-445f-a545-d0e6eabfe1c96
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSY699638dd-3a53-445f-a545-d0e6eabfe1c96
351264buprenorphine HCl 2 MG Sublingual TabletPSN9f7b0a28-f937-4d4d-b793-ca3468bd28e01
351264buprenorphine 2 MG Sublingual TabletSCD9f7b0a28-f937-4d4d-b793-ca3468bd28e01
351264buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual TabletSY9f7b0a28-f937-4d4d-b793-ca3468bd28e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-182-307288801823030 TABLET in 1 BOTTLE (72888-182-30) 30 tablet2024-01-23NoNoCurrent
72888-182-907288801829090 TABLET in 1 BOTTLE (72888-182-90) 90 tablet2024-01-23NoNoCurrent