NDC 12496-1204-03 - 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
- 12496-1204
- Requested NDC
- 12496-1204-03
- Package NDCs from labels
- 12496-1204-1, 12496-1204-3, 12496-1204-03
- 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 | Type |
|---|---|---|---|
| Suboxone | 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. | 2026-01-08 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12496-1204-1 | Suboxone | 1 in 1 POUCH | FILM, SOLUBLE | 1 | 37 | |
| 12496-1204-3 | Suboxone | 30 in 1 CARTON | FILM, SOLUBLE | 30 | 37 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 12496-1204 | SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.] | 33 | Current NDC, Legacy NDC, 2 package rows | 20241114_8a5edcf9-828c-4f97-b671-268ab13a8ecd.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 12496-1204-1 | EA - Each | 12496-1204 | 98f4ae28-c45e-4a13-9070-07eecd03bc82 | 1 | 2013-02-13 |
| 12496-1204-3 | EA - Each | 12496-1204 | 664ceaa6-d02c-47d5-96de-4d658c312dbd | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 8091a73d-9ecd-4578-a57b-5d85a2c5a16a | 2026-08-25 | Warnings | F850569PQR |
| Rohto All-In-One | HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE | The Mentholatum Company | 43e690e4-b381-46e3-838c-33aef5bdadde | 2026-08-20 | Warnings | 3NXW29V3WO |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE | REMEDYREPACK INC. | 4124c4ad-ef62-4c95-8e57-0d843862ae71 | 2026-08-17 | Warnings, Adverse reactions | 56W8MW3EN1 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE | REMEDYREPACK INC. | 43027750-d218-49e5-867f-c941736d2056 | 2026-08-17 | Warnings, Adverse reactions | 56W8MW3EN1 |
| NARCAN | NALOXONE HYDROCHLORIDE NASAL | Emergent Devices Inc. | a0ebc83d-2892-40de-bc0a-775ce90b30db | 2026-08-17 | Warnings | F850569PQR |
| Leader Dry Eye Relief Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | CARDINAL HEALTH 110, LLC. DBA LEADER | 2ded4bda-b3c3-4521-8701-5c8446fd148b | 2026-08-17 | Warnings | 3NXW29V3WO |
| Buprenorphine and Naloxone Sublingual Film | BUPRENORPHINE AND NALOXONE | Redpharm Drug | 58d2c995-c0cf-a007-e063-6394a90a3f77 | 2026-08-12 | Warnings, Adverse reactions | 1010604 56W8MW3EN1 |
| Dr. Shitong Photon Energy Eye Care Liquid | TETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUID | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 58ace434-55ef-17ef-e063-6294a90aa878 | 2026-08-10 | Warnings | 3NXW29V3WO |
| IDkit HP ONE | CITRIC ACID ANHYDROUS AND 13C UREA | Meridian Bioscience Israel Ltd | 8baab7a7-5d20-46ad-9c4a-762992ef6b51 | 2026-07-28 | Warnings, Adverse reactions | 2968PHW8QP |
| buprenorphine and naloxone | BUPRENORPHINE AND NALOXONE | Hikma Pharmaceuticals USA Inc. | 713db2c6-0544-4633-b874-cfbeaf93db89 | 2026-07-26 | Warnings, Adverse reactions | 56W8MW3EN1 |
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | Advagen Pharma Ltd | 699638dd-3a53-445f-a545-d0e6eabfe1c9 | 2026-07-17 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine HCl | BUPRENORPHINE HCL | REMEDYREPACK INC. | e1aac2bb-cb83-46cb-9a29-502a62010667 | 2026-07-17 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Artificial Tears | ARTIFICIAL TEARS | AvPAK | f18bebf2-1936-658f-e053-2a95a90a5012 | 2026-07-07 | Warnings | 3NXW29V3WO |
| Buprenorphine | BUPRENORPHINE | REMEDYREPACK INC. | aa86a438-1ebf-4c08-bf27-38f1e81efb3a | 2026-07-07 | Warnings, Adverse reactions | 56W8MW3EN1 |
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | REMEDYREPACK INC. | 11686845-f5fd-4e96-8a4f-9b132bf48840 | 2026-07-07 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Sportpharm LLC | 3750bf77-342c-4469-8bbb-f71009aa03fa | 2026-07-02 | Warnings | F850569PQR |
| BUPRENORPHINE | BUPRENORPHINE | Unit Dose Solutions, Inc. | 5578cd5c-c860-6e8a-e063-6394a90a56c7 | 2026-06-30 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Naloxone Hydrochloride | NALXONE HYDROCHLORIDE | Civica, Inc. | 21d20dff-6efe-481e-a5a0-9c80ded73ca9 | 2026-06-30 | Warnings, Adverse reactions | F850569PQR |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | aa132031-9d12-45b4-81e0-4a5877661379 | 2026-06-29 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine | BUPRENORPHINE | Bryant Ranch Prepack | 655e3e52-03be-496c-978a-5cffc74b2ae4 | 2026-06-29 | Warnings, Adverse reactions | 56W8MW3EN1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.