FDA.reportPublic FDA data

Buprenorphine and Naloxone

Product NDC
0121-2036
11-digit product format
001212036
Labeler code
0121
Product ID
0121-2036_68da75ec-2a4c-4456-b556-4258975d59d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine hydrochloride and naloxone hydrochloride
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Application
ANDA204431
Marketing category
ANDA
Marketing start
2023-09-05
Substance
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active strength
8; 2 mg/1; mg/1
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA], 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 and Naloxone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1
NALOXONE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF850569PQR, 56W8MW3EN1
Rxcui351266, 351267

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
68654759-f50b-79ef-24c5-544d94fe7d87Product name320251114
c955d208-c333-9bd7-be34-d7e12986d44eProduct name620250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304Product name120250204
caa6391e-3db3-c912-335f-61b5fc00aa12Product name920240110
08a295bb-88df-4ab0-a120-a75a789a74f1Product name120231013
65a3bc34-04ff-4cf1-aad9-c7d92a062f6dProduct name120231003
e951cdf3-f269-4d97-a7d5-c1c3d7283a7dProduct name320230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
100316cc-94a9-474e-97ad-9b5c6ddec605Product name520230125
f327b80c-8fa2-404b-838a-df3eec141cf2Product name120221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119Product name120220511
539bc5d3-546b-4af6-9c31-058ce6c459d3Product name220220210
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9Product name120211026
31e16ab2-c562-4617-a3e8-ed285320e16eProduct name120180201
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
a5920611-4285-f024-69b9-39ff338b81eaProduct name520170609
0b8c7273-1da3-495f-909a-7cf1e96d2361Product name120161212
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0121-2036-302024-01-30C16284748780-11030e365-43ff-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for BUPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE Sublingual Tablets for sublingual administration CIII Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-2036-30Buprenorphine and Naloxone30 in 1 BOTTLE, PLASTICTABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-2036-30EA - Each0121-2036b5e6b3a4-1342-4c52-817c-31f6337502f512023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-2036BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [PAI HOLDINGS, LLC DBA PHARMACEUTICAL ASSOCIATES, INC. AND DBA PAI PHARMA]6Current NDC, 1 package rows20240711_d5b011ef-f1be-47f2-8f8b-07553f36193c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351266buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual TabletPSNd5b011ef-f1be-47f2-8f8b-07553f36193c7
351267buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual TabletPSNd5b011ef-f1be-47f2-8f8b-07553f36193c7
351266buprenorphine 2 MG / naloxone 0.5 MG Sublingual TabletSCDd5b011ef-f1be-47f2-8f8b-07553f36193c7
351267buprenorphine 8 MG / naloxone 2 MG Sublingual TabletSCDd5b011ef-f1be-47f2-8f8b-07553f36193c7
351266buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual TabletSYd5b011ef-f1be-47f2-8f8b-07553f36193c7
351267buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual TabletSYd5b011ef-f1be-47f2-8f8b-07553f36193c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-2036-300012120363030 TABLET in 1 BOTTLE, PLASTIC (0121-2036-30) 30 tablet2023-09-05NoNoHistorical