FDA.reportPublic FDA data

buprenorphine hydrochloride and naloxone hydrochloride dihydrate

Product NDC
0054-0189
11-digit product format
000540189
Labeler code
0054
Product ID
0054-0189_baa6b446-3f71-42c6-a9bb-8526e8f9e81c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA203326
Marketing category
ANDA
Marketing start
2014-06-27
Substance
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
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 hydrochloride and naloxone hydrochloride dihydrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1
NALOXONE HYDROCHLORIDE DIHYDRATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii56W8MW3EN1, 5Q187997EE
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
0054-0189-132024-01-30C16284748780-11030e365-1440-111a-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
0054-0189-132024-01-30C16284748780-11030e365-1440-111a-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
0054-0189-132024-01-30C16284748780-11030e365-1440-111a-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
0054-0189-132024-01-30C16284748780-11030e365-1440-111a-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
0054-0189-13buprenorphine hydrochloride and naloxone hydrochloride dihydrate30 in 1 BOTTLETABLET3031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0189-13EA - Each0054-018997e051f0-f1b5-4c7c-9bec-939baf0a0d2012014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPRENORPHINE HYDROCHLORIDEACTIVE INGREDIENT56W8MW3EN1BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2
NALOXONE HYDROCHLORIDE DIHYDRATEACTIVE INGREDIENT5Q187997EEBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2
BUPRENORPHINEACTIVE MOIETY40D3SCR4GZBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2
NALOXONEACTIVE MOIETY36B82AMQ7NBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ABUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0189BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [HIKMA PHARMACEUTICALS USA INC.]27Current NDC, Legacy NDC, 1 package rows20250323_713db2c6-0544-4633-b874-cfbeaf93db89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351266buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual TabletPSN713db2c6-0544-4633-b874-cfbeaf93db8931
351267buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual TabletPSN713db2c6-0544-4633-b874-cfbeaf93db8931
351266buprenorphine 2 MG / naloxone 0.5 MG Sublingual TabletSCD713db2c6-0544-4633-b874-cfbeaf93db8931
351267buprenorphine 8 MG / naloxone 2 MG Sublingual TabletSCD713db2c6-0544-4633-b874-cfbeaf93db8931
351266buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual TabletSY713db2c6-0544-4633-b874-cfbeaf93db8931
351267buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual TabletSY713db2c6-0544-4633-b874-cfbeaf93db8931
351266buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual TabletPSNc5fbec69-e7de-44a8-b9fa-0378ae61a9fe9
351267buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual TabletPSNc5fbec69-e7de-44a8-b9fa-0378ae61a9fe9
351266buprenorphine 2 MG / naloxone 0.5 MG Sublingual TabletSCDc5fbec69-e7de-44a8-b9fa-0378ae61a9fe9
351267buprenorphine 8 MG / naloxone 2 MG Sublingual TabletSCDc5fbec69-e7de-44a8-b9fa-0378ae61a9fe9
351266buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual TabletSYc5fbec69-e7de-44a8-b9fa-0378ae61a9fe9
351267buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual TabletSYc5fbec69-e7de-44a8-b9fa-0378ae61a9fe9
351267buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual TabletPSN4124c4ad-ef62-4c95-8e57-0d843862ae717
351267buprenorphine 8 MG / naloxone 2 MG Sublingual TabletSCD4124c4ad-ef62-4c95-8e57-0d843862ae717
351267buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual TabletSY4124c4ad-ef62-4c95-8e57-0d843862ae717
351266buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual TabletPSN4f6e0056-b19d-0d0e-e063-6294a90a16e52
351266buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual TabletPSN99a5b62f-bc08-44f4-abb8-300520d2162a2
351267buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual TabletPSN4f6e0056-b19d-0d0e-e063-6294a90a16e52
351267buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual TabletPSN99a5b62f-bc08-44f4-abb8-300520d2162a2
351266buprenorphine 2 MG / naloxone 0.5 MG Sublingual TabletSCD4f6e0056-b19d-0d0e-e063-6294a90a16e52
351266buprenorphine 2 MG / naloxone 0.5 MG Sublingual TabletSCD99a5b62f-bc08-44f4-abb8-300520d2162a2
351267buprenorphine 8 MG / naloxone 2 MG Sublingual TabletSCD4f6e0056-b19d-0d0e-e063-6294a90a16e52
351267buprenorphine 8 MG / naloxone 2 MG Sublingual TabletSCD99a5b62f-bc08-44f4-abb8-300520d2162a2
351266buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual TabletSY99a5b62f-bc08-44f4-abb8-300520d2162a2
351266buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual TabletSY4f6e0056-b19d-0d0e-e063-6294a90a16e52
351267buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual TabletSY99a5b62f-bc08-44f4-abb8-300520d2162a2
351267buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual TabletSY4f6e0056-b19d-0d0e-e063-6294a90a16e52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0189-130005401891330 TABLET in 1 BOTTLE (0054-0189-13) 30 tablet2014-06-270000-00-00NoNoCurrent