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 6 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATERedpharm Drug44f2e26f-4586-5204-e063-6394a90a47d52026-01-23Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HClBUPRENORPHINE HCLCamber Pharmaceuticals, Inc.b52cea0e-688f-4beb-bf7d-f228b81dbd232026-01-23Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEMylan Pharmaceuticals Inc.557d8d4d-8751-431c-b18e-9d5cf23fc5792026-01-15Warnings, Adverse reactionsExact identifier
rxcui: 1307056
rxcui: 1307061
rxcui: 1010604
rxcui: 1010600
unii: 56W8MW3EN1
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAvKARE1766a7f1-d301-945f-e063-6294a90ac6f42026-01-14WarningsExact identifier
unii: F850569PQR
RiViveNALOXONE HYDROCHLORIDEHarm Reduction Therapeutics, Inc.1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d2026-01-13WarningsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDESina Health Inc2879294f-9af9-459e-e063-6394a90a08202026-01-12Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEDr.Reddys Laboratories Inc718756d7-0131-b173-6c45-5ee039b311b02026-01-12Warnings, Adverse reactionsExact identifier
rxcui: 1010604
rxcui: 1010600
unii: 56W8MW3EN1
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEDr.Reddys Laboratories Inc72dc1ec0-7c59-a587-4ffd-c40ef79e6fb22026-01-12Warnings, Adverse reactionsExact identifier
rxcui: 1307056
rxcui: 1307061
unii: 56W8MW3EN1
BuprenorphineBUPRENORPHINEAvPAK1408cd8f-a0b5-6be7-e063-6394a90a0b412026-01-08Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEAvPAKb955054b-b37d-4079-4fed-5939b763ecb42026-01-08Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltdb5d40220-f194-4835-b70c-f304ecb222d52026-01-06WarningsExact identifier
unii: F850569PQR
BELBUCABUPRENORPHINE HYDROCHLORIDEBioDelivery Sciences International Incbc2b7a3d-72cf-497c-95b0-ba2b71f63c642026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEDr. Reddy's Laboratories, Inc.b1303f15-c48b-a44d-b28a-72f370094e022026-01-01Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Buprenorphine and Naloxone Sublingual FilmBUPRENORPHINE AND NALOXONEAlvogen Inc.4210afeb-474c-d842-d68e-af7e0021851a2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 1307056
rxcui: 1307061
rxcui: 1010604
rxcui: 1010600
unii: 56W8MW3EN1
Buprenorphine HydrochlorideBUPRENORPHINE HYDROCHLORIDEHospira, Inc.23aa1bb3-cecf-4e62-29bb-48488bb66fc32025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Discount Drug Mart Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Discount Drug Martf7fd53be-e501-d97f-e053-6394a90ad4092025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Exchange Select Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Army and Air Force Exchange Service9e478343-8ae7-823e-e053-2995a90a84ed2025-12-30WarningsExact identifier
unii: 3NXW29V3WO
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
unii: 3NXW29V3WO
Core Values Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Liberty Procurement Co. Inc.f8285f68-c40c-19a8-e053-6394a90aacad2025-12-30WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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