Application 018024
- Type
- NDA
- Sponsor
- PAR PHARM INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NUBAIN | NALBUPHINE HYDROCHLORIDE | INJECTABLE;INJECTION | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | NUBAIN | NALBUPHINE HYDROCHLORIDE | INJECTABLE;INJECTION | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | NUBAIN | NALBUPHINE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No |
| 004 | NUBAIN | NALBUPHINE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No |
| 005 | NUBAIN | NALBUPHINE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 200MG/10ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018024-001 | NUBAIN | NALBUPHINE HYDROCHLORIDE | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | ||
| N018024-002 | NUBAIN | NALBUPHINE HYDROCHLORIDE | 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1982-05-27 | |
| N018024-003 | NUBAIN | NALBUPHINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | ||
| N018024-004 | NUBAIN | NALBUPHINE HYDROCHLORIDE | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | ||
| N018024-005 | NUBAIN | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1984-03-02 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N018024-001 | NUBAIN | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N018024-002 | NUBAIN | 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1982-05-27 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N018024-003 | NUBAIN | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N018024-004 | NUBAIN | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N018024-005 | NUBAIN | 200MG/10ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1984-03-02 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N018024-001 | NUBAIN | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018024-002 | NUBAIN | 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1982-05-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018024-003 | NUBAIN | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018024-004 | NUBAIN | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018024-005 | NUBAIN | 200MG/10ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1984-03-02 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N018024-001 | NUBAIN | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018024-002 | NUBAIN | 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1982-05-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018024-003 | NUBAIN | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018024-004 | NUBAIN | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018024-005 | NUBAIN | 200MG/10ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1984-03-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018024-001 | NUBAIN | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018024-002 | NUBAIN | 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1982-05-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018024-003 | NUBAIN | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018024-004 | NUBAIN | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018024-005 | NUBAIN | 200MG/10ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1984-03-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018024-001 | NUBAIN | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018024-002 | NUBAIN | 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1982-05-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018024-003 | NUBAIN | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018024-004 | NUBAIN | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018024-005 | NUBAIN | 200MG/10ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1984-03-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018024-001 | NUBAIN | 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018024-002 | NUBAIN | 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1982-05-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018024-003 | NUBAIN | 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018024-004 | NUBAIN | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018024-005 | NUBAIN | 200MG/10ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1984-03-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018024-001 | NUBAIN | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018024-002 | NUBAIN | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-05-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018024-001 | NUBAIN | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018024-002 | NUBAIN | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-05-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018024-001 | NUBAIN | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018024-002 | NUBAIN | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-05-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018024-001 | NUBAIN | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018024-002 | NUBAIN | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-05-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018024-001 | NUBAIN | 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018024-002 | NUBAIN | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-05-27 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| Nalbuphine Hydrochloride | NALBUPHINE HYDROCHLORIDE | Hospira, Inc. | a99fe500-f52b-483c-807c-178f1a78a02b | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | NALBUPHINE HYDROCHLORIDE |
| Nalbuphine Hydrochloride | NALBUPHINE HYDROCHLORIDE | Henry Schein, Inc. | dd621bfa-ce48-4c27-b247-a6d885f70b72 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | NALBUPHINE HYDROCHLORIDE |
| Nalbuphine Hydrochloride | NALBUPHINE HYDROCHLORIDE | Henry Schein, Inc. | 4ef2c0dc-3ab4-4bb1-aff0-523e3c23ad2d | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | NALBUPHINE HYDROCHLORIDE |
| Nalbuphine Hydrochloride | NALBUPHINE HYDROCHLORIDE | Hospira, Inc. | 6025e8d4-5083-4c3a-58a0-050e7b0b6150 | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | NALBUPHINE HYDROCHLORIDE |
| Nalbuphine Hydrochloride | NALBUPHINE HYDROCHLORIDE | ProPharma Distribution | 38569b5f-fb37-135e-e063-6294a90a54df | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | NALBUPHINE HYDROCHLORIDE |
| Nalbuphine Hydrochloride | NALBUPHINE HYDROCHLORIDE | Henry Schein, Inc. | 596826ff-e471-4d4f-9a73-2a34e2af2dd6 | 2025-05-21 | Boxed warning, Warnings, Adverse reactions | NALBUPHINE HYDROCHLORIDE |
| Nalbuphine hydrochloride | NALBUPHINE HYDROCHLORIDE | Somerset Therapeutics, LLC | a3221c05-5822-4ab8-b589-0e3939b91a68 | 2025-03-26 | Boxed warning, Adverse reactions | NALBUPHINE HYDROCHLORIDE |
| Nalbuphine hydrochloride | NALBUPHINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 292b0d0e-f222-d384-e063-6394a90acd44 | 2024-12-13 | Boxed warning, Adverse reactions | NALBUPHINE HYDROCHLORIDE |
| Nalbuphine Hydrochloride | NALBUPHINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 28f274a4-62c4-4e54-e063-6394a90a2200 | 2024-12-10 | Boxed warning, Warnings, Adverse reactions | NALBUPHINE HYDROCHLORIDE |
| Nalbuphine hydrochloride | NALBUPHINE HYDROCHLORIDE | Somerset Therapeutics, LLC | d82dafac-cce7-445a-8127-2a10b6d947ca | 2024-09-26 | Boxed warning, Adverse reactions | NALBUPHINE HYDROCHLORIDE |
| Nalbuphine Hydrochloride | NALBUPHINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 6bde2184-5643-3ec6-e053-2991aa0a115f | 2023-05-23 | Boxed warning, Warnings, Adverse reactions | NALBUPHINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84706 | SUPPL | 2026-01-07 |
| 84555 | SUPPL | 2025-12-29 |
| 77027 | SUPPL | 2023-12-19 |
| 76949 | SUPPL | 2023-12-18 |
| 60298 | SUPPL | 2019-10-08 |
| 60283 | SUPPL | 2019-10-07 |
| 46404 | SUPPL | 2016-12-21 |
| 46213 | SUPPL | 2016-12-19 |
| 20103 | SUPPL | 2007-08-06 |
| 40772 | SUPPL | 2007-07-18 |
| 33394 | SUPPL | 2005-08-31 |
| 13982 | SUPPL | 2005-08-31 |
| 786 | SUPPL | 2003-05-30 |