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 8 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BuprenorphineBUPRENORPHINERedpharm Drug3dd00186-1f1f-642a-e063-6294a90a6d202025-12-02Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.ab19b011-0a51-4f04-9881-d9fc7cae95ae2025-11-25Exact identifier
unii: 1Q73Q2JULR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEStrategic Sourcing Services LLC577fbd57-7054-4536-86c1-d43bc99cc7b12025-11-19WarningsExact identifier
unii: F850569PQR
Earthmed Soothe Chewable OrangeCITRIC ACIDEarthmed LLC439543fe-ceb9-4c5c-e063-6294a90a9b702025-11-14WarningsExact identifier
unii: 2968PHW8QP
AQUACETIC-30CLEANING SOLUTION FOR HEMODIALYSIS MACHINESAqua Medica, S.A. de C.V.040775ab-41bd-cd36-e063-6394a90a08aa2025-11-10WarningsExact identifier
unii: 2968PHW8QP
CITRACID-50DESINFECTANT SOLUTION FOR HEMODIALYSIS MACHINEAqua Medica, S.A. de C.V.040713e7-67cd-8eb0-e063-6394a90aa2a92025-11-10WarningsExact identifier
unii: 2968PHW8QP
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHenry Schein, Inc.ddeebc32-9aab-4a2f-8c87-74335d17d5ef2025-10-28Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEProPharma Distribution3f2bb95a-aeca-c0b7-e063-6394a90a627b2025-09-19Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.e6467385-6990-498c-8a0e-f4a40ef33cb72025-09-02Warnings, Adverse reactionsExact identifier
unii: F850569PQR
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEAMERISOURCE BERGENcce38c13-0d2f-49bb-94fa-6f2bbb4d59842025-08-31WarningsExact identifier
unii: F850569PQR
PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDELupin Pharmaceuticals,Inc.017ef042-40aa-44c9-baa8-037f063568452025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: F850569PQR
KLOXXADONALOXONE HCLHikma Specialty USA Inc.ebf0f833-c1c0-487c-8f29-01fa8c61b6cb2025-08-25Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Medique Medi SeltzerASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnifirst First Aid Corporation528da9d9-2a52-4c16-b7b2-61b3eee1abea2025-08-19WarningsExact identifier
unii: 2968PHW8QP
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst3ba53405-5e72-c035-e063-6294a90ac0b12025-08-05Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEFresenius Kabi USA, LLC201fdedf-1736-4e52-9d7d-de14292547fd2025-07-31Warnings, Adverse reactionsExact identifier
unii: F850569PQR
BUPRENORPHINEBUPRENORPHINEBryant Ranch Prepacka7da638f-f590-4577-bff9-15a91c6e79172025-07-29Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEProPharma Distribution3856ea66-29b8-8fc2-e063-6394a90ac33a2025-07-18Warnings, Adverse reactionsExact identifier
unii: F850569PQR
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEBelleview Biosciences LLC3245e0e5-5e7f-c3f7-e063-6394a90ac2582025-07-07Adverse reactionsExact identifier
unii: 1Q73Q2JULR
buprenorphine hydrochlorideBUPRENORPHINE HYDROCHLORIDEA-S Medication Solutionsc1398d85-d4bb-4426-8ecf-a50400910d812025-05-28Warnings, Adverse reactionsExact identifier
unii: 56W8MW3EN1
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: 1Q73Q2JULR

Reported adverse events (FAERS/openFDA)#

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