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 hydrochloride and naloxone hydrochloride dihydrate | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE | Major Pharmaceuticals | c5fbec69-e7de-44a8-b9fa-0378ae61a9fe | 2026-03-03 | Warnings, Adverse reactions | 56W8MW3EN1 |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Henry Schein, Inc | bd65e3fe-cd7a-4855-8f55-8cc3a0921ccc | 2026-03-02 | Warnings, Adverse reactions | F850569PQR |
| buprenorphine hydrochloride | BUPRENORPHINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 442831cf-9636-433a-9a12-e9a8cd31f72a | 2026-02-28 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine and Naloxone | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | d5b011ef-f1be-47f2-8f8b-07553f36193c | 2026-02-28 | Warnings, Adverse reactions | F850569PQR 56W8MW3EN1 |
| Tricitrates | TRICITRATES | Chartwell Governmental & Specialty RX, LLC. | c4ff0407-3930-4c48-afd4-d2cb3e1b18f4 | 2026-02-25 | Warnings, Adverse reactions | 2968PHW8QP 1Q73Q2JULR |
| Potassium Citrate and Citric Acid | POTASSIUM CITRATE AND CITRIC ACID | Chartwell Governmental & Specialty RX, LLC. | fd57a176-7faf-4053-b348-6ba5f192f05a | 2026-02-25 | Warnings, Adverse reactions | 2968PHW8QP |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | Redpharm Drug | 300ae3d0-464c-d0be-e063-6294a90a7f9d | 2026-02-21 | Warnings, Adverse reactions | 1010600 56W8MW3EN1 |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | Unit Dose Solutions, Inc. | 4b301ad7-ac0e-f849-e063-6394a90a27d5 | 2026-02-19 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine | BUPRENORPHINE | Sun Pharmaceutical Industries, Inc. | 9fd1f18f-0b0f-4059-b603-19ecbf0ed63a | 2026-02-11 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | REMEDYREPACK INC. | 68df290c-d776-4cfc-9565-332eb56c4723 | 2026-02-10 | Warnings, Adverse reactions | F850569PQR |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | Sun Pharmaceutical Industries, Inc. | 91b68606-05de-4586-ae31-07e8cc9160cf | 2026-02-10 | Warnings, Adverse reactions | 56W8MW3EN1 |
| naloxone hydrochloride | NALOXONE HYDROCHLORIDE | Lifestar Pharma LLC | aef6719c-cd71-46ee-b7b1-1806b939bf3e | 2026-02-09 | Warnings, Adverse reactions | F850569PQR |
| BUPRENORPHINE | BUPRENORPHINE | A-S Medication Solutions | bfb02ea5-22f2-432e-afc8-f1dbe2ea0614 | 2026-02-06 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | Actavis Pharma, Inc. | 6cccf229-9611-4b6f-8f1b-acc8ff1ed3f8 | 2026-02-06 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine HCl and Naloxone HCl | BUPRENORPHINE AND NALOXONE | Amneal Pharmaceuticals LLC | 17b63f10-c9df-44be-80fa-6f1c305583b8 | 2026-02-02 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Additive Formula 3 | DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINE | Terumo BCT, Ltd | 9a5247a1-cc05-442d-b2d0-950f887f03c2 | 2026-01-30 | Warnings, Adverse reactions | 2968PHW8QP |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | Camber Pharmaceuticals, Inc. | 221195e4-de08-414c-af08-a611a74789de | 2026-01-30 | Warnings, Adverse reactions | 1307056 1307061 1010604 1010600 F850569PQR 56W8MW3EN1 |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID MONOHYDRATE | Atlantic Biologicals Corp. | 42d837ae-2578-46df-92d2-24774964aaad | 2026-01-28 | Adverse reactions | 1Q73Q2JULR |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | Camber Pharmaceuticals, Inc. | 5ab2d4e4-3c8c-413a-b147-23eafbde313a | 2026-01-28 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine | BUPRENORPHINE | Hikma Pharmaceuticals USA Inc. | 1bf8b35a-b769-465c-a2f8-099868dfcd2f | 2026-01-24 | Warnings, Adverse reactions | 56W8MW3EN1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.