FDA.reportPublic FDA data

Zubsolv

Product NDC
54123-907
11-digit product format
541230907
Labeler code
54123
Product ID
54123-907_8c67e97f-118f-4226-972a-a9031ef6f5ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine hydrochloride and naloxone hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
SUBLINGUAL
Labeler
Orexo US, Inc.
Application
NDA204242
Marketing category
NDA
Marketing start
2013-07-04
Substance
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Active strength
.7; .18 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zubsolv
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE.7 mg/1
NALOXONE HYDROCHLORIDE.18 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF850569PQR, 56W8MW3EN1
Rxcui1431076, 1431083, 1431102, 1431104, 1597568, 1597570, 1597573, 1597575, 1666338, 1666385, 1864412, 1864414

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54123-907-302021-02-17C16284748780-1ba0f9c33-5bce-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ZUBSOLV ® safely and effectively. See full prescribing information for ZUBSOLV. ZUBSOLV (buprenorphine and naloxone sublingual tablets), CIII Initial U.S. Approval: 2002
54123-907-302021-01-29C16284748780-1ba0f9c33-5bce-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ZUBSOLV ® safely and effectively. See full prescribing information for ZUBSOLV. ZUBSOLV (buprenorphine and naloxone sublingual tablets), CIII Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54123-907-30Zubsolv10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1027
54123-907-30Zubsolv3 in 1 CARTONTABLET, ORALLY DISINTEGRATING327

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54123-907-30EA - Each54123-9076171d97f-e6df-42d4-abbb-72fa580c7c8012017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPRENORPHINE HYDROCHLORIDEACTIVE INGREDIENT56W8MW3EN1ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5
NALOXONE HYDROCHLORIDEACTIVE INGREDIENTF850569PQRZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5
BUPRENORPHINEACTIVE MOIETY40D3SCR4GZZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5
NALOXONEACTIVE MOIETY36B82AMQ7NZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3AZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54123-907ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]26Current NDC, Legacy NDC, 2 package rows20250524_5f5cfcfe-d52b-49e6-8fe4-550477332dd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1864412buprenorphine 0.7 MG / naloxone 0.18 MG Sublingual TabletPSN5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1431076buprenorphine 1.4 MG / naloxone 0.36 MG Sublingual TabletPSN5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1597568buprenorphine 11.4 MG / naloxone 2.9 MG Sublingual TabletPSN5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1666338buprenorphine 2.9 MG / naloxone 0.71 MG Sublingual TabletPSN5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1431102buprenorphine 5.7 MG / naloxone 1.4 MG Sublingual TabletPSN5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1597573buprenorphine 8.6 MG / naloxone 2.1 MG Sublingual TabletPSN5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1864414Zubsolv 0.7 MG / 0.18 MG Sublingual TabletPSN5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1431083zubsolv 1.4 MG / 0.36 MG Sublingual TabletPSN5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1597570zubsolv 11.4 MG / 2.9 MG Sublingual TabletPSN5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1666385zubsolv 2.9 MG / 0.71 MG Sublingual TabletPSN5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1431104zubsolv 5.7 MG / 1.4 MG Sublingual TabletPSN5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1597575zubsolv 8.6 MG / 2.1 MG Sublingual TabletPSN5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1864414buprenorphine 0.7 MG / naloxone 0.18 MG Sublingual Tablet [Zubsolv]SBD5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1431083buprenorphine 1.4 MG / naloxone 0.36 MG Sublingual Tablet [Zubsolv]SBD5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1597570buprenorphine 11.4 MG / naloxone 2.9 MG Sublingual Tablet [Zubsolv]SBD5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1666385buprenorphine 2.9 MG / naloxone 0.71 MG Sublingual Tablet [Zubsolv]SBD5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1431104buprenorphine 5.7 MG / naloxone 1.4 MG Sublingual Tablet [Zubsolv]SBD5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1597575buprenorphine 8.6 MG / naloxone 2.1 MG Sublingual Tablet [Zubsolv]SBD5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1864412buprenorphine 0.7 MG / naloxone 0.18 MG Sublingual TabletSCD5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1431076buprenorphine 1.4 MG / naloxone 0.36 MG Sublingual TabletSCD5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1597568buprenorphine 11.4 MG / naloxone 2.9 MG Sublingual TabletSCD5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1666338buprenorphine 2.9 MG / naloxone 0.71 MG Sublingual TabletSCD5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1431102buprenorphine 5.7 MG / naloxone 1.4 MG Sublingual TabletSCD5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1597573buprenorphine 8.6 MG / naloxone 2.1 MG Sublingual TabletSCD5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1431076buprenorphine (as buprenorphine hydrochloride) 1.4 MG / naloxone (as naloxone hydrochloride dihydrate) 0.36 MG Sublingual TabletSY5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1597568buprenorphine (as buprenorphine hydrochloride) 11.4 MG / naloxone (as naloxone hydrochloride dihydrate) 2.9 MG Sublingual TabletSY5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1666338buprenorphine (as buprenorphine hydrochloride) 2.9 MG / naloxone (as naloxone hydrochloride dihydrate) 0.71 MG Sublingual TabletSY5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1431102buprenorphine (as buprenorphine hydrochloride) 5.7 MG / naloxone (as naloxone hydrochloride dihydrate) 1.4 MG Sublingual TabletSY5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1597573buprenorphine (as buprenorphine hydrochloride) 8.6 MG / naloxone (as naloxone hydrochloride dihydrate) 2.1 MG Sublingual TabletSY5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1597570Zubsolv (buprenorphine 11.4 MG / naloxone 2.9 MG) Sublingual TabletSY5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1597575Zubsolv (buprenorphine 8.6 MG / naloxone 2.1 MG) Sublingual TabletSY5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1864414Zubsolv 0.7 MG / 0.18 MG Sublingual TabletSY5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1431083Zubsolv 1.4/0.36 (buprenorphine HCl / naloxone HCl dihydrate) Sublingual TabletSY5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1431083Zubsolv 1.4/0.36 Sublingual TabletSY5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1666385Zubsolv 2.9/0.71 Sublingual TabletSY5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1431104Zubsolv 5.7/1.4 (buprenorphine HCl / naloxone HCl dihydrate) Sublingual TabletSY5f5cfcfe-d52b-49e6-8fe4-550477332dd227
1431104Zubsolv 5.7/1.4 Sublingual TabletSY5f5cfcfe-d52b-49e6-8fe4-550477332dd227

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54123-907-30541230907303 BLISTER PACK in 1 CARTON (54123-907-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2013-07-040000-00-00NoNoCurrent