FDA.reportPublic FDA data

Buprenorphine HCl and Naloxone HCl

Product NDC
63629-7269
11-digit product format
636297269
Labeler code
63629
Product ID
63629-7269_ff43dbe4-d5eb-4eb9-a779-0066c59b633f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine and Naloxone
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Bryant Ranch Prepack
Application
ANDA203136
Marketing category
ANDA
Marketing start
2013-02-22
Substance
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active strength
2; .5 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 HCl and Naloxone HCl
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1
NALOXONE HYDROCHLORIDE DIHYDRATE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5Q187997EE, 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
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
0b8c7273-1da3-495f-909a-7cf1e96d2361Product name120161212
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
973da5bf-b1f9-4de0-81ee-7ca066c98ca4Product name120160712
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7269-12024-05-17C16284748780-11030e365-5fdc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use B UPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for B UPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002
63629-7269-12024-01-30C16284748780-11030e365-5fdc-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use B UPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for B UPRENORPHINE AND NALOXONE SUBLINGUAL TABLETS. BUPRENORPHINE AND NALOXONE sublingual tablets, CIII Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7269-1Buprenorphine HCl and Naloxone HCl30 in 1 BOTTLETABLET301007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPRENORPHINE HYDROCHLORIDEACTIVE INGREDIENT56W8MW3EN1BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
NALOXONE HYDROCHLORIDE DIHYDRATEACTIVE INGREDIENT5Q187997EEBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
BUPRENORPHINEACTIVE MOIETY40D3SCR4GZBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
NALOXONEACTIVE MOIETY36B82AMQ7NBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
MANNITOLINACTIVE INGREDIENT3OWL53L36ABUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7269BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1006Current NDC, Legacy NDC, 1 package rows20240518_2aaad1a7-a0fd-4dd5-bb53-03afad8f10b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351266buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual TabletPSN2aaad1a7-a0fd-4dd5-bb53-03afad8f10b91007
351267buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual TabletPSN2aaad1a7-a0fd-4dd5-bb53-03afad8f10b91007
351266buprenorphine 2 MG / naloxone 0.5 MG Sublingual TabletSCD2aaad1a7-a0fd-4dd5-bb53-03afad8f10b91007
351267buprenorphine 8 MG / naloxone 2 MG Sublingual TabletSCD2aaad1a7-a0fd-4dd5-bb53-03afad8f10b91007
351266buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual TabletSY2aaad1a7-a0fd-4dd5-bb53-03afad8f10b91007
351267buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual TabletSY2aaad1a7-a0fd-4dd5-bb53-03afad8f10b91007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7269-16362972690130 TABLET in 1 BOTTLE (63629-7269-1) 30 tablet2024-04-020000-00-00NoNoCurrent