FDA.reportPublic FDA data

buprenorphine hydrochloride

Product NDC
0121-1019
11-digit product format
001211019
Labeler code
0121
Product ID
0121-1019_2c22b6ad-acee-4045-b5c5-025afe061b79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine hydrochloride
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Application
ANDA090622
Marketing category
ANDA
Marketing start
2023-10-12
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
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
0121-1019-30buprenorphine hydrochloride30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1019-30EA - Each0121-1019d96edb55-47fc-43ba-af08-617fef5b65f412023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1019BUPRENORPHINE HYDROCHLORIDE TABLET [PAI HOLDINGS, LLC DBA PHARMACEUTICAL ASSOCIATES, INC. AND DBA PAI PHARMA]5Current NDC, 1 package rows20240711_442831cf-9636-433a-9a12-e9a8cd31f72a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351264buprenorphine HCl 2 MG Sublingual TabletPSN442831cf-9636-433a-9a12-e9a8cd31f72a6
351265buprenorphine HCl 8 MG Sublingual TabletPSN442831cf-9636-433a-9a12-e9a8cd31f72a6
351264buprenorphine 2 MG Sublingual TabletSCD442831cf-9636-433a-9a12-e9a8cd31f72a6
351265buprenorphine 8 MG Sublingual TabletSCD442831cf-9636-433a-9a12-e9a8cd31f72a6
351264buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual TabletSY442831cf-9636-433a-9a12-e9a8cd31f72a6
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSY442831cf-9636-433a-9a12-e9a8cd31f72a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-1019-300012110193030 TABLET in 1 BOTTLE (0121-1019-30) 30 tablet2023-10-12NoNoCurrent