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 |
|---|---|---|---|---|---|---|
| Harris Teeter Eye Drops Artificial Tears | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Harris Teeter, LLC. | f82957d9-c4ad-a914-e053-6294a90aac50 | 2025-12-30 | Warnings | 3NXW29V3WO |
| CVS Gentle Tears | DEXTRAN 70, HYPROMELLOSE | CVS Pharmacy, Inc. | 9b1ea0eb-c34f-6603-e053-2995a90a6a95 | 2025-12-30 | Warnings | 3NXW29V3WO |
| Buprenorphine and Naloxone Sublingual Film | BUPRENORPHINE AND NALOXONE | Redpharm Drug | 2fd16916-95a9-14b5-e063-6294a90a79fa | 2025-12-27 | Warnings, Adverse reactions | 1010604 56W8MW3EN1 |
| Zubsolv | BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | Orexo US, Inc. | 5f5cfcfe-d52b-49e6-8fe4-550477332dd2 | 2025-12-27 | Warnings, Adverse reactions | F850569PQR 56W8MW3EN1 |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | BPI Labs LLC | 5de44ee7-6525-4857-9a67-8882e96dbeb5 | 2025-12-26 | Warnings, Adverse reactions | F850569PQR |
| Buprenorphine HCl | BUPRENORPHINE HCL | Redpharm Drug | 301eaed5-8499-ad95-e063-6294a90a58f5 | 2025-12-23 | Warnings, Adverse reactions | 56W8MW3EN1 |
| Suboxone | BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE | INDIVIOR INC. | 8a5edcf9-828c-4f97-b671-268ab13a8ecd | 2025-12-22 | Warnings, Adverse reactions | NDA022410 12496-1204-1 12496-1202-1 12496-1208-1 12496-1212-1 12496-1202-3 12496-1204-3 12496-1212-3 12496-1208-3 12496-1202 12496-1208 12496-1212 12496-1204 12496120201 1010606 1307056 1307063 1307061 1010604 1307058 1010603 1010600 ad5a289a-6285-4b2d-b7ad-e4812169dd58 8a5edcf9-828c-4f97-b671-268ab13a8ecd F850569PQR 56W8MW3EN1 |
| Artificial Tears | GLYCERIN | Geri-Care Pharmaceuticals, Corp | 7cc437e3-bad9-59be-e053-2991aa0a1da3 | 2025-12-19 | Warnings | 3NXW29V3WO |
| Sterile Cord Blood Collection Unit (MSC128D) | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION | Maco Productions | 251fd4cb-4aa4-4473-9f89-968da856eb77 | 2025-12-18 | Warnings | 2968PHW8QP 1Q73Q2JULR |
| Sterile Cord Blood Collection Unit (MSC127D) | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION | Maco Productions | 75a008b2-9666-4bfa-ab18-6d09b43b2215 | 2025-12-18 | Warnings | 2968PHW8QP 1Q73Q2JULR |
| Buprenorphine Hydrochloride | BUPRENORPHINE HYDROCHLORIDE | Par Health USA, LLC | 34767dda-ce52-4f98-a45f-bb5cee0cd5e6 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 56W8MW3EN1 |
| Pall Sterile Cord Blood Collection Unit | STERILE CORD BLOOD COLLECTION UNIT | Global Life Sciences Solutions USA LLC | aa9340b7-cc63-e17d-e053-2a95a90ad4d9 | 2025-12-18 | Warnings | 2968PHW8QP 1Q73Q2JULR |
| STERILE CORD BLOOD COLLECTION UNIT (MSC123D) | ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE | Maco Productions | e3b456ec-4578-485f-a696-8a343505f30b | 2025-12-16 | Warnings | 2968PHW8QP 1Q73Q2JULR |
| Artificial Tears | GLYCERIN | NuCare Pharmaceuticals,Inc. | 97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d | 2025-12-15 | Warnings | 3NXW29V3WO |
| Buprenorphine and Naloxone | BUPRENORPHINE AND NALOXONE | Redpharm Drug | 374530e2-3b2e-77d7-e063-6394a90a37c9 | 2025-12-11 | Warnings, Adverse reactions | 56W8MW3EN1 |
| PaxLyte | LEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULE | Jaymac Pharmaceuticals | f520b130-61b3-443e-aaf6-91e094e7a334 | 2025-12-08 | Warnings, Adverse reactions | 2968PHW8QP 1Q73Q2JULR |
| Narcan | NALOXONE HYDROCHLORIDE | Emergent Devices Inc. | 724df050-5332-4d0a-9a5f-17bf08a547e1 | 2025-12-05 | Warnings, Adverse reactions | F850569PQR |
| ZIMHI | NALOXONE HYDROCHLORIDE | ZMI Pharma Inc. | 523c0909-bff6-4010-988a-53de18b7cb3f | 2025-12-04 | Warnings, Adverse reactions | F850569PQR |
| Alka-Seltzer Heartburn | ANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED) | Bayer HealthCare LLC. | 55158e50-0327-2043-e054-00144ff8d46c | 2025-12-04 | Warnings | 2968PHW8QP |
| Alka-Seltzer Gold | ALKA-SELTZER GOLD | Bayer HealthCare LLC. | 0824bedb-413b-2fa0-e054-00144ff88e88 | 2025-12-04 | Warnings | 2968PHW8QP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.