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 |
|---|---|---|---|---|---|---|
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Eugia US LLC | 8bcf426a-b4fc-4f24-9ad0-fb26168a0b56 | 2025-05-14 | Warnings, Adverse reactions | F850569PQR |
| Phexx | LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE | Evofem, Inc. | 14b01a15-9b47-4be3-bb2e-a2010eab429e | 2025-05-02 | Warnings, Adverse reactions | 2968PHW8QP |
| Tricitrates | TRICITRATES | Chartwell RX, LLC | 2a80ea6b-6334-4c33-a35e-a5cb2939fbcb | 2025-04-28 | Warnings, Adverse reactions | 2968PHW8QP 1Q73Q2JULR |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID | Kesin Pharma Corporation | 3140f8fe-0644-7561-e063-6394a90a2c28 | 2025-04-21 | Adverse reactions | 1Q73Q2JULR |
| Potassium Citrate and Citric Acid | POTASSIUM CITRATE AND CITRIC ACID | Chartwell RX, LLC | 978a5a9d-f0ca-4308-a84b-3b132263bbb8 | 2025-04-09 | Warnings, Adverse reactions | 2968PHW8QP |
| Alka-Seltzer Heartburn Relief Lemon Lime | ANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED) | Bayer Healthcare LLC | cc21af24-9a5b-6831-e053-2a95a90a0af4 | 2025-04-01 | Warnings | 2968PHW8QP |
| Buprenorphine HCl | BUPRENORPHINE HCL | Bryant Ranch Prepack | d5a8c41e-413e-4d48-9739-d158e5681dd0 | 2025-03-28 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine Hydrochloride | BUPRENORPHINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | adc1167e-910e-4d7b-abdc-751d3df0c3dc | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | 56W8MW3EN1 |
| Alka-Seltzer Heartburn Relief Extra Strength | ANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED) | Bayer Healthcare LLC | dc1641f8-54c2-0d86-e053-2995a90a1dce | 2025-03-11 | Warnings | 2968PHW8QP |
| Addiclenz | ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUM | Deseret Biologicals, Inc. | 25036c26-1c21-4e5a-b4db-b8e177458341 | 2025-03-11 | Warnings | 1Q73Q2JULR |
| Buprenorphine | BUPRENORPHINE | Clinical Solutions Wholesale, LLC | 9d976ee7-9509-49da-89fd-48d7e712697b | 2025-02-17 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine Hydrochloride | BUPRENORPHINE HYDROCHLORIDE | Somerset Therapeutics, LLC | 74e40c51-853b-4e7f-b3cb-a27af29e1cbf | 2025-02-11 | Boxed warning, Warnings, Adverse reactions | 56W8MW3EN1 |
| Buprenorphine | BUPRENORPHINE | Clinical Solutions Wholesale, LLC | 023c7816-21b1-4f85-be36-9e32d5935c19 | 2025-02-03 | Warnings, Adverse reactions | 56W8MW3EN1 |
| naloxone hydrochloride | NALOXONE HYDROCHLORIDE | NorthStar RxLLC | d4c44b74-4e36-4b63-80eb-64ce99ccb39f | 2025-01-27 | Warnings, Adverse reactions | F850569PQR |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Henry Schein, Inc. | d39635a4-ddb3-4d32-8211-eb84c78e9f59 | 2025-01-27 | Warnings, Adverse reactions | F850569PQR |
| Anticoagulant Citrate Dextrose A ACD-A | ANTICOAGULANT CITRATE DEXTROSE A ACD-A | Arteriocyte Medical Systems, Inc. | b850deac-161f-4bb0-ac7f-bceac2a230c0 | 2025-01-23 | 2968PHW8QP 1Q73Q2JULR | |
| ACD A | DEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE | Terumo BCT Ltd | 570770de-9b48-4fc1-a1ee-06002ca9504f | 2025-01-22 | 2968PHW8QP 1Q73Q2JULR | |
| Anticoagulant Citrate Dextrose (ACD-A) | DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATE | Terumo BCT, Ltd | 0130d7c8-d067-4528-beb7-166559c33be9 | 2025-01-21 | Warnings, Adverse reactions | 2968PHW8QP 1Q73Q2JULR |
| Soothe Chewable | CITRIC ACID | Carolina Cannabis Creations LLC | 04a27a71-b7b2-12aa-e063-6294a90a312f | 2025-01-15 | Warnings | 2968PHW8QP |
| Soothe Chewable | CITRIC ACID | Carolina Cannabis Creations LLC | 04a7720f-1e74-7578-e063-6394a90a5eae | 2025-01-15 | Warnings | 2968PHW8QP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.