Nalbuphine Hydrochloride
- Product NDC
- 52584-083
- 11-digit product format
- 525840083
- Labeler code
- 52584
- Product ID
- 52584-083_0e1346b6-7c47-4957-b0be-849a84b18a89
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nalbuphine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- General Injectables and Vaccines,Inc.
- Application
- ANDA070918
- Marketing category
- ANDA
- Marketing start
- 2021-04-19
- Marketing end
- 0000-00-00
- Substance
- NALBUPHINE HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 52584-083 | D | Discontinued by firm | 2026-09-14 | ||
| excluded package | package | 52584-083 | 52584-083-61 | D | Discontinued by firm | 2026-09-14 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52584-083-61 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52584-083-61 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52584-083-61 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52584-083-61 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52584-083-61 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52584-083-61 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52584-083-61 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52584-083-61 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52584-083-61 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52584-083-61 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52584-083-61 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52584-083-61 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A070918-001 | NALBUPHINE HYDROCHLORIDE | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RS | 1989-02-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A070918-001 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RS | 1989-02-03 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RS | 1989-02-03 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RS | 1989-02-03 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RS | 1989-02-03 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 200MG/10ML (20MG/ML) | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | AP | RS | 1989-02-03 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A070918-001 | NALBUPHINE HYDROCHLORIDE | 20MG/ML | INJECTABLE / INJECTION | AP | RS | 1989-02-03 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A070918-001 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A070918-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A070918-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A070918-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A070918-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A070918-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A070918-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A070918-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A070918-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A070918-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A070918-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A070918-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A070918-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A070918-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A070918-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A070918-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A070918-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A070918-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A070918-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A070918-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A070918-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A070918-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A070918-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A070918-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A070918-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A070918-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A070918-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A070918-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A070918-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A070918-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A070918-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A070918-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A070918-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A070918-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A070918-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A070918-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A070918-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A070918-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A070918-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A070918-001 | AP | 1 | f41ea6bd6efb… |
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. | 6025e8d4-5083-4c3a-58a0-050e7b0b6150 | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | 070918 ANDA070918 |
| NALBUPHINE HCI | NALBUPHINE HCI | HF Acquisition Co LLC, DBA HealthFirst | 96128b54-24d6-88a3-e053-2a95a90a1c9c | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | 070918 ANDA070918 |
| Nalbuphine Hydrochloride | NALBUPHINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 28f274a4-62c4-4e54-e063-6394a90a2200 | 2024-12-10 | Boxed warning, Warnings, Adverse reactions | 070918 ANDA070918 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52584-083-61 | 52584008361 | 1 VIAL, MULTI-DOSE in 1 BAG (52584-083-61) > 10 mL in 1 VIAL, MULTI-DOSE | 2021-04-19 | 0000-00-00 | No | No | Current |