NDC 12496-1202-01 - Suboxone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
12496-1202
Requested NDC
12496-1202-01
Package NDCs from labels
12496-1202-1, 12496-1202-3, 12496-1202-01
Manufacturer
INDIVIOR INC. | SGS North America Inc. | Aquestive Therapeutics | Alcami Carolinas Corporation | Infinity Labs IN, Inc | Sharp Packaging Services, LLC | SpecGx LLC | Macfarlan Smith Limited | INDIVIOR UK Limited | Butterworth Laboratories Ltd | QUOTIENT SCIENCES (ALNWICK) LIMITED | Siegfried AG | Veranova, L.P. | PPD Development, L.P.
Effective date
2026-01-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SuboxoneINDIVIOR INC. | SGS North America Inc. | Aquestive Therapeutics | Alcami Carolinas Corporation | Infinity Labs IN, Inc | Sharp Packaging Services, LLC | SpecGx LLC | Macfarlan Smith Limited | INDIVIOR UK Limited | Butterworth Laboratories Ltd | QUOTIENT SCIENCES (ALNWICK) LIMITED | Siegfried AG | Veranova, L.P. | PPD Development, L.P.2026-01-08HUMAN PRESCRIPTION DRUG LABEL
Suboxone - Bryant Ranch Prepack | Monosol Rx LLC | Reckitt Benckiser Healthcare (UK) LtdBryant Ranch Prepack | Monosol Rx LLC | Reckitt Benckiser Healthcare (UK) Ltd2012-10-12HUMAN PRESCRIPTION DRUG LABEL

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 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 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
BUPRENORPHINE HYDROCHLORIDEACTIVE INGREDIENT56W8MW3EN1SUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]2
NALOXONE HYDROCHLORIDEACTIVE INGREDIENTF850569PQRSUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]2
BUPRENORPHINEACTIVE MOIETY40D3SCR4GZSUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]2
NALOXONEACTIVE MOIETY36B82AMQ7NSUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9SUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]2
MALTITOLINACTIVE INGREDIENTD65DG142WKSUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSUBOXONE (BUPRENORPHINE AND NALOXONE) FILM, SOLUBLE [BRYANT RANCH PREPACK]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONERedpharm Drug5005a6c8-9a3b-a99a-e063-6294a90aac132026-04-22Warnings, Adverse reactionsExact identifier
rxcui: 1010600
unii: F850569PQR
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEBryant Ranch Prepack63aaa6cc-8574-4990-8239-6fdeffce92c82026-04-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEUnit Dose Solutions, Inc.4f979409-f9a2-d3a2-e063-6394a90accd02026-04-16Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEAveva Drug Delivery Systems Inc.cb112448-49a1-4209-bcdb-7cfae6501f512026-04-07Warnings, Adverse reactionsExact identifier
rxcui: 1307056
rxcui: 1307061
rxcui: 1010604
rxcui: 1010600
unii: F850569PQR
unii: 56W8MW3EN1
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 2968PHW8QP
unii: 1Q73Q2JULR
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepackcd0a90c6-32cc-4114-8573-86ac85503bdf2026-04-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEBryant Ranch Prepack2aaad1a7-a0fd-4dd5-bb53-03afad8f10b92026-04-03Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEBluePoint Laboratories327004b0-560a-84d0-e063-6294a90aa7432026-04-02WarningsExact identifier
unii: F850569PQR
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: 3NXW29V3WO
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEINGENUS PHARMACEUTICALS, LLC4951ec29-609b-4836-b0e4-0d9c1d6ae6fe2026-03-23Warnings, Adverse reactionsExact identifier
rxcui: 1307056
rxcui: 1307061
rxcui: 1010604
rxcui: 1010600
unii: F850569PQR
unii: 56W8MW3EN1
Buprenorphine HClBUPRENORPHINE HCLREMEDYREPACK INC.69a647c0-bc09-4ee2-aeb3-ef286caf25e52026-03-23Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co. LLC. DBA HealthFirst4d66b96a-acbb-2292-e063-6294a90af7882026-03-19Warnings, Adverse reactionsExact identifier
unii: F850569PQR
buprenorphine hydrochloride and naloxone hydrochloride dihydrateBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEClinical Solutions Wholesale, LLC99a5b62f-bc08-44f4-abb8-300520d2162a2026-03-06Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: 3NXW29V3WO
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEClinical Solutions Wholesale, LLC8f2b94dc-f42f-45d5-8274-9e748ec20ef02026-03-05Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
REZENOPYNALOXONE HCLScienture LLC5bb502aa-014f-4a36-8972-42a9439168fe2026-03-03Warnings, Adverse reactionsExact identifier
unii: F850569PQR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.