FDA.reportPublic FDA data

Suboxone

Product NDC
12496-1202
11-digit product format
124961202
Labeler code
12496
Product ID
12496-1202_ad5a289a-6285-4b2d-b7ad-e4812169dd58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
buprenorphine hydrochloride, naloxone hydrochloride
Dosage form
FILM, SOLUBLE
Route
BUCCAL; SUBLINGUAL
Labeler
INDIVIOR INC.
Application
NDA022410
Marketing category
NDA
Marketing start
2010-09-13
Substance
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
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
Suboxone
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii56W8MW3EN1, F850569PQR
Rxcui1010600, 1010603, 1010604, 1010606, 1307056, 1307058, 1307061, 1307063

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12496-1202-1Suboxone1 in 1 POUCHFILM, SOLUBLE137
12496-1202-3Suboxone30 in 1 CARTONFILM, SOLUBLE3037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12496-1202-1EA - Each12496-1202f0c6efd3-02da-4c60-8db1-7e0852ade18d12012-07-24
12496-1202-3EA - Each12496-1202cceb10a2-3557-40a7-a9bb-b2586ecd6b4d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
buprenorphine hydrochlorideACTIVE INGREDIENT56W8MW3EN1SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]9
naloxone hydrochlorideACTIVE INGREDIENTF850569PQRSUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]9
buprenorphineACTIVE MOIETY40D3SCR4GZSUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]9
naloxoneACTIVE MOIETY36B82AMQ7NSUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]9
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G9SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]9
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPSUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]9
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]9
maltitolINACTIVE INGREDIENTD65DG142WKSUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]9
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRSUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12496-1202SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]33Current NDC, Legacy NDC, 2 package rows20241114_8a5edcf9-828c-4f97-b671-268ab13a8ecd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307061buprenorphine HCl 12 MG / naloxone HCl 3 MG Sublingual FilmPSN8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010600buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual FilmPSN8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1307056buprenorphine HCl 4 MG / naloxone HCl 1 MG Sublingual FilmPSN8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010604buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual FilmPSN8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1307063Suboxone 12 MG / 3 MG Sublingual FilmPSN8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010603Suboxone 2 MG / 0.5 MG Sublingual FilmPSN8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1307058Suboxone 4 MG / 1 MG Sublingual FilmPSN8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010606Suboxone 8 MG / 2 MG Sublingual FilmPSN8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1307063buprenorphine 12 MG / naloxone 3 MG Sublingual Film [Suboxone]SBD8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010603buprenorphine 2 MG / naloxone 0.5 MG Sublingual Film [Suboxone]SBD8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1307058buprenorphine 4 MG / naloxone 1 MG Sublingual Film [Suboxone]SBD8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010606buprenorphine 8 MG / naloxone 2 MG Sublingual Film [Suboxone]SBD8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1307061buprenorphine 12 MG / naloxone 3 MG Sublingual FilmSCD8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010600buprenorphine 2 MG / naloxone 0.5 MG Sublingual FilmSCD8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1307056buprenorphine 4 MG / naloxone 1 MG Sublingual FilmSCD8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010604buprenorphine 8 MG / naloxone 2 MG Sublingual FilmSCD8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1307061buprenorphine 12 MG / naloxone 3 MG Sublingual FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010600buprenorphine 2 MG / naloxone 0.5 MG Buccal FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010600buprenorphine 2 MG / naloxone 0.5 MG Sublingual FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1307056buprenorphine 4 MG / naloxone 1 MG Buccal FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1307056buprenorphine 4 MG / naloxone 1 MG Sublingual FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010604buprenorphine 8 MG / naloxone 2 MG Buccal FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010604buprenorphine 8 MG / naloxone 2 MG Sublingual FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1307063Suboxone 12/3 (buprenorphine HCl / naloxone HCl dihydrate) Sublingual FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1307063Suboxone 12/3 Sublingual FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010603Suboxone 2/0.5 (buprenorphine HCl / naloxone HCl dihydrate) Sublingual FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010603Suboxone 2/0.5 Sublingual FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1307058Suboxone 4/1 (buprenorphine HCl / naloxone HCl dihydrate) Sublingual FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1307058Suboxone 4/1 Sublingual FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010606Suboxone 8/2 (buprenorphine HCl / naloxone HCl dihydrate) Sublingual FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37
1010606Suboxone 8/2 Sublingual FilmSY8a5edcf9-828c-4f97-b671-268ab13a8ecd37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12496-1202-1124961202011 in 1 POUCHHistorical
12496-1202-31249612020330 POUCH in 1 CARTON (12496-1202-3) / 1 FILM, SOLUBLE in 1 POUCH (12496-1202-1) 30 pouch2010-09-130000-00-00NoNoCurrent