FDA.reportPublic FDA data

Buprenorphine

Product NDC
0054-0177
11-digit product format
000540177
Labeler code
0054
Product ID
0054-0177_e59c3c4f-a9cc-412b-b001-b9e430f537c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Buprenorphine
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA078633
Marketing category
ANDA
Marketing start
2009-10-08
Substance
BUPRENORPHINE HYDROCHLORIDE
Active strength
8 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 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
0054-0177-13Buprenorphine30 in 1 BOTTLETABLET3032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0177-13EA - Each0054-01771bf3c40b-c21c-43e1-ac48-80d57966e69812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPRENORPHINE HYDROCHLORIDEACTIVE INGREDIENT56W8MW3EN1BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]8
BUPRENORPHINEACTIVE MOIETY40D3SCR4GZBUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]8
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]8
MANNITOLINACTIVE INGREDIENT3OWL53L36ABUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]8
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]8
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0177BUPRENORPHINE TABLET [HIKMA PHARMACEUTICALS USA INC.]27Current NDC, Legacy NDC, 1 package rows20250514_1bf8b35a-b769-465c-a2f8-099868dfcd2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351264buprenorphine HCl 2 MG Sublingual TabletPSN1bf8b35a-b769-465c-a2f8-099868dfcd2f32
351265buprenorphine HCl 8 MG Sublingual TabletPSN1bf8b35a-b769-465c-a2f8-099868dfcd2f32
351264buprenorphine 2 MG Sublingual TabletSCD1bf8b35a-b769-465c-a2f8-099868dfcd2f32
351265buprenorphine 8 MG Sublingual TabletSCD1bf8b35a-b769-465c-a2f8-099868dfcd2f32
351264buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual TabletSY1bf8b35a-b769-465c-a2f8-099868dfcd2f32
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSY1bf8b35a-b769-465c-a2f8-099868dfcd2f32
351265buprenorphine HCl 8 MG Sublingual TabletPSN69a647c0-bc09-4ee2-aeb3-ef286caf25e517
351265buprenorphine 8 MG Sublingual TabletSCD69a647c0-bc09-4ee2-aeb3-ef286caf25e517
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSY69a647c0-bc09-4ee2-aeb3-ef286caf25e517
351264buprenorphine HCl 2 MG Sublingual TabletPSNdba586f9-e3f2-4b9c-849b-907c81a5a0ef9
351265buprenorphine HCl 8 MG Sublingual TabletPSNdba586f9-e3f2-4b9c-849b-907c81a5a0ef9
351264buprenorphine 2 MG Sublingual TabletSCDdba586f9-e3f2-4b9c-849b-907c81a5a0ef9
351265buprenorphine 8 MG Sublingual TabletSCDdba586f9-e3f2-4b9c-849b-907c81a5a0ef9
351264buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual TabletSYdba586f9-e3f2-4b9c-849b-907c81a5a0ef9
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSYdba586f9-e3f2-4b9c-849b-907c81a5a0ef9
351265buprenorphine HCl 8 MG Sublingual TabletPSNd5a8c41e-413e-4d48-9739-d158e5681dd07
351265buprenorphine 8 MG Sublingual TabletSCDd5a8c41e-413e-4d48-9739-d158e5681dd07
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSYd5a8c41e-413e-4d48-9739-d158e5681dd07
351264buprenorphine HCl 2 MG Sublingual TabletPSN3a7418a2-bd6e-4082-b0fe-a5498e7b944a4
351265buprenorphine HCl 8 MG Sublingual TabletPSN3a7418a2-bd6e-4082-b0fe-a5498e7b944a4
351264buprenorphine 2 MG Sublingual TabletSCD3a7418a2-bd6e-4082-b0fe-a5498e7b944a4
351265buprenorphine 8 MG Sublingual TabletSCD3a7418a2-bd6e-4082-b0fe-a5498e7b944a4
351264buprenorphine 2 MG (as buprenorphine HCl 2.16 MG) Sublingual TabletSY3a7418a2-bd6e-4082-b0fe-a5498e7b944a4
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSY3a7418a2-bd6e-4082-b0fe-a5498e7b944a4
351265buprenorphine HCl 8 MG Sublingual TabletPSNf27cb3bc-c512-fbb2-e053-2a95a90a72242
351265buprenorphine 8 MG Sublingual TabletSCDf27cb3bc-c512-fbb2-e053-2a95a90a72242
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSYf27cb3bc-c512-fbb2-e053-2a95a90a72242
351265buprenorphine HCl 8 MG Sublingual TabletPSN248524c6-4c8b-a450-e063-6394a90a81ef1
351265buprenorphine 8 MG Sublingual TabletSCD248524c6-4c8b-a450-e063-6394a90a81ef1
351265buprenorphine 8 MG (as buprenorphine HCl 8.64 MG) Sublingual TabletSY248524c6-4c8b-a450-e063-6394a90a81ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0177-130005401771330 TABLET in 1 BOTTLE (0054-0177-13) 30 tablet2009-10-080000-00-00NoNoCurrent