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 | 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 |
| Suboxone - Bryant Ranch Prepack | Monosol Rx LLC | Reckitt Benckiser Healthcare (UK) Ltd | Bryant Ranch Prepack | Monosol Rx LLC | Reckitt Benckiser Healthcare (UK) Ltd | 2012-10-12 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 12496-1202-1 | Suboxone | 1 in 1 POUCH | FILM, SOLUBLE | 1 | 37 | |
| 12496-1202-3 | Suboxone | 30 in 1 CARTON | FILM, SOLUBLE | 30 | 37 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 12496-1202 | 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 |
|---|---|---|---|---|---|
| 12496-1202-1 | EA - Each | 12496-1202 | f0c6efd3-02da-4c60-8db1-7e0852ade18d | 1 | 2012-07-24 |
| 12496-1202-3 | EA - Each | 12496-1202 | cceb10a2-3557-40a7-a9bb-b2586ecd6b4d | 1 | 2012-07-24 |
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 |
|---|---|---|---|---|---|---|
| BUPRENORPHINE AND NALOXONE | BUPRENORPHINE AND NALOXONE | Ascend Laboratories, LLC | 2e807ed0-6df3-47b5-b7ee-b421c5bf0aa7 | 2026-06-29 | Warnings, Adverse reactions | F850569PQR 56W8MW3EN1 |
| Leukotrap WB System | CPDA-1 BLOOD BAG COLLECTION SYSTEM | GVS TM INC | 54fd8a72-0527-df0c-e063-6294a90abe75 | 2026-06-24 | 2968PHW8QP 1Q73Q2JULR | |
| Leukotrap WB System | CPDA-1 BLOOD BAG COLLECTION SYSTEM | GVS TM INC | 54fddca1-b40c-7af0-e063-6294a90a410e | 2026-06-24 | 2968PHW8QP 1Q73Q2JULR | |
| Leukotrap WB System | CPDA-1 BLOOD BAG COLLECTION SYSTEM | GVS TM INC | 54fdf83e-f641-1f69-e063-6394a90ab750 | 2026-06-24 | 2968PHW8QP 1Q73Q2JULR | |
| Rohto Sun and Sport | HYPROMELLOSE, POVIDONE | The Mentholatum Company | 8bcc8882-b886-4b55-9bc4-d4b92a41358f | 2026-06-19 | Warnings | 3NXW29V3WO |
| Rohto Dual Light Relief | HYPROMELLOSE, POVIDONE | The Mentholatum Company | 1b597f83-d7f1-cf93-e063-6394a90a99f7 | 2026-06-19 | Warnings | 3NXW29V3WO |
| Pentazocine and naloxone | PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | Actavis Pharma, Inc. | a28450a0-ac93-4235-b9a6-58cdf24773cb | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | F850569PQR |
| BUPRENORPHINE | BUPRENORPHINE | Unit Dose Solutions, Inc. | 5479b218-a388-2c3c-e063-6294a90a0e85 | 2026-06-17 | Warnings, Adverse reactions | 56W8MW3EN1 |
| BUPRENORPHINE | BUPRENORPHINE | Bryant Ranch Prepack | 966adb01-71b4-4e0b-bbc6-b83da9987aa2 | 2026-06-16 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine | BUPRENORPHINE | Major Pharmaceuticals | dba586f9-e3f2-4b9c-849b-907c81a5a0ef | 2026-06-16 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | Bryant Ranch Prepack | fe023dbf-e165-4b7f-a211-bd14696f1e2c | 2026-06-16 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | Bryant Ranch Prepack | 4b1df792-f56c-4c0c-92b0-a887f4225567 | 2026-06-16 | Warnings, Adverse reactions | 56W8MW3EN1 |
| ACD A | CITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE | Terumo BCT, Ltd. | 395aec48-198a-4aed-8e38-7accfb3232f9 | 2026-06-15 | Warnings, Adverse reactions | 2968PHW8QP |
| Buprenorphine and Naloxone Sublingual Film | BUPRENORPHINE AND NALOXONE | Redpharm Drug | 541bf5be-8b2c-99bc-e063-6294a90a2f17 | 2026-06-13 | Warnings, Adverse reactions | 1010604 56W8MW3EN1 |
| Zubsolv | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | Edenbridge Pharmaceuticals LLC. | 57583c1d-9c44-4503-917d-68dba7377bd1 | 2026-06-12 | Warnings, Adverse reactions | F850569PQR 56W8MW3EN1 |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | Bryant Ranch Prepack | 17419c34-23a3-429c-8037-150f42536ec7 | 2026-06-12 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID MONOHYDRATE | Cardinal Health 107, LLC | b3d5225c-0ee4-481e-b9ec-bc5e1321096d | 2026-06-12 | Adverse reactions | 1Q73Q2JULR |
| GUNA-CELL | ACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINC | Guna spa | 90db80ed-c037-4e8f-a7f6-304a65f9fe22 | 2026-06-11 | Warnings | 2968PHW8QP |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 53ed164c-dd09-4ea4-e063-6294a90a2434 | 2026-06-11 | Warnings, Adverse reactions | F850569PQR |
| GUNA-FLAM | ACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT - | Guna spa | 7bda7eb0-8fd5-42d9-b336-39920bfc964d | 2026-06-10 | Warnings | 2968PHW8QP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.